Trial Outcomes & Findings for Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise (NCT NCT04292535)
NCT ID: NCT04292535
Last Updated: 2021-06-21
Results Overview
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
During the 20 minute exercise/control period and the cognitive assessments.
Results posted on
2021-06-21
Participant Flow
Participants were recruited from the mid-Michigan area.
177 individuals were assessed for eligibility. 61 individuals were excluded (58 for failing medical screening, 1 diabetic, 1 unable to exercise, 1 history of epilepsy) 116 individuals were randomized using a serial stratification approach.
Participant milestones
| Measure |
Passive Control - Placebo
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 20 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
9
|
8
|
8
|
9
|
8
|
10
|
8
|
8
|
7
|
7
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
9
|
8
|
8
|
9
|
8
|
8
|
8
|
8
|
7
|
6
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Passive Control - Placebo
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 20 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Condition stopped due to Blood Sugar Below 70 mg/dL
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Report of Dizziness
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Equipment Failure
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Baseline characteristics by cohort
| Measure |
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=10 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=9 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=9 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
20.8 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
20.7 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
20.0 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
21.9 years
STANDARD_DEVIATION 3.1 • n=4 Participants
|
19.6 years
STANDARD_DEVIATION 1.3 • n=21 Participants
|
20.8 years
STANDARD_DEVIATION 2.5 • n=8 Participants
|
23.1 years
STANDARD_DEVIATION 3.9 • n=8 Participants
|
19.8 years
STANDARD_DEVIATION 1.5 • n=24 Participants
|
19.9 years
STANDARD_DEVIATION 1.5 • n=42 Participants
|
21.8 years
STANDARD_DEVIATION 3.9 • n=42 Participants
|
21.3 years
STANDARD_DEVIATION 3.9 • n=42 Participants
|
20.2 years
STANDARD_DEVIATION 1.8 • n=42 Participants
|
20.1 years
STANDARD_DEVIATION 1.4 • n=36 Participants
|
20.1 years
STANDARD_DEVIATION 2.4 • n=36 Participants
|
20.7 years
STANDARD_DEVIATION 2.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
72 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
44 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
109 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
96 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
116 Participants
n=24 Participants
|
|
Education
|
14.4 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
13.7 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 2.8 • n=4 Participants
|
13.6 years
STANDARD_DEVIATION 2.7 • n=21 Participants
|
13.4 years
STANDARD_DEVIATION 2.3 • n=8 Participants
|
15.6 years
STANDARD_DEVIATION 2.6 • n=8 Participants
|
13.0 years
STANDARD_DEVIATION 1.1 • n=24 Participants
|
13.2 years
STANDARD_DEVIATION 1.9 • n=42 Participants
|
15.1 years
STANDARD_DEVIATION 3.4 • n=42 Participants
|
14.0 years
STANDARD_DEVIATION 2.8 • n=42 Participants
|
13.7 years
STANDARD_DEVIATION 2.1 • n=42 Participants
|
13.4 years
STANDARD_DEVIATION 1.4 • n=36 Participants
|
13.2 years
STANDARD_DEVIATION 1.9 • n=36 Participants
|
13.9 years
STANDARD_DEVIATION 2.2 • n=24 Participants
|
|
WASI-II (IQ)
|
104.7 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
105.0 units on a scale
STANDARD_DEVIATION 7.6 • n=7 Participants
|
98.3 units on a scale
STANDARD_DEVIATION 8.1 • n=5 Participants
|
110.0 units on a scale
STANDARD_DEVIATION 6.4 • n=4 Participants
|
113.6 units on a scale
STANDARD_DEVIATION 10.1 • n=21 Participants
|
120.6 units on a scale
STANDARD_DEVIATION 12.7 • n=8 Participants
|
110.7 units on a scale
STANDARD_DEVIATION 10.5 • n=8 Participants
|
104.4 units on a scale
STANDARD_DEVIATION 4.3 • n=24 Participants
|
110.8 units on a scale
STANDARD_DEVIATION 18.8 • n=42 Participants
|
107.7 units on a scale
STANDARD_DEVIATION 8.0 • n=42 Participants
|
110.8 units on a scale
STANDARD_DEVIATION 4.1 • n=42 Participants
|
103.5 units on a scale
STANDARD_DEVIATION 8.7 • n=42 Participants
|
108.2 units on a scale
STANDARD_DEVIATION 16.8 • n=36 Participants
|
101.2 units on a scale
STANDARD_DEVIATION 17.8 • n=36 Participants
|
107.5 units on a scale
STANDARD_DEVIATION 9.9 • n=24 Participants
|
|
Fasting blood glucose (mg/dL)
|
94.1 mg/dL
STANDARD_DEVIATION 6.9 • n=5 Participants
|
96.0 mg/dL
STANDARD_DEVIATION 10.3 • n=7 Participants
|
99.0 mg/dL
STANDARD_DEVIATION 9.3 • n=5 Participants
|
91.9 mg/dL
STANDARD_DEVIATION 3.5 • n=4 Participants
|
96.4 mg/dL
STANDARD_DEVIATION 6.5 • n=21 Participants
|
94.4 mg/dL
STANDARD_DEVIATION 9.4 • n=8 Participants
|
97.8 mg/dL
STANDARD_DEVIATION 7.3 • n=8 Participants
|
92.2 mg/dL
STANDARD_DEVIATION 9.4 • n=24 Participants
|
97.4 mg/dL
STANDARD_DEVIATION 7.9 • n=42 Participants
|
87.1 mg/dL
STANDARD_DEVIATION 9.6 • n=42 Participants
|
93.1 mg/dL
STANDARD_DEVIATION 9.3 • n=42 Participants
|
96.3 mg/dL
STANDARD_DEVIATION 7.3 • n=42 Participants
|
92.7 mg/dL
STANDARD_DEVIATION 9.6 • n=36 Participants
|
96.0 mg/dL
STANDARD_DEVIATION 9.5 • n=36 Participants
|
94.6 mg/dL
STANDARD_DEVIATION 8.6 • n=24 Participants
|
|
Aerobic fitness percentile
|
44.7 percentile
STANDARD_DEVIATION 28.8 • n=5 Participants
|
26.2 percentile
STANDARD_DEVIATION 10.7 • n=7 Participants
|
68.5 percentile
STANDARD_DEVIATION 12.9 • n=5 Participants
|
54.5 percentile
STANDARD_DEVIATION 24.0 • n=4 Participants
|
35.9 percentile
STANDARD_DEVIATION 23.1 • n=21 Participants
|
53.6 percentile
STANDARD_DEVIATION 36.3 • n=8 Participants
|
41.7 percentile
STANDARD_DEVIATION 26.9 • n=8 Participants
|
59.2 percentile
STANDARD_DEVIATION 26.9 • n=24 Participants
|
45.2 percentile
STANDARD_DEVIATION 23.7 • n=42 Participants
|
48.7 percentile
STANDARD_DEVIATION 34.5 • n=42 Participants
|
52.0 percentile
STANDARD_DEVIATION 28.5 • n=42 Participants
|
55.8 percentile
STANDARD_DEVIATION 23.2 • n=42 Participants
|
71.8 percentile
STANDARD_DEVIATION 23.2 • n=36 Participants
|
28.8 percentile
STANDARD_DEVIATION 10.0 • n=36 Participants
|
46.9 percentile
STANDARD_DEVIATION 24.8 • n=24 Participants
|
PRIMARY outcome
Timeframe: During the 20 minute exercise/control period and the cognitive assessments.The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=9 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=9 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=10 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
9 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=9 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=9 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=10 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Manifestation of Any Symptom Following the Protocol
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Prior to intranasal insulin administration relative to 30 minutes followingThe effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect Size for Change in Behavioral Index of Inhibitory Control - RT
|
-0.20 cohens d
Interval -0.4 to 0.01
|
-0.25 cohens d
Interval -0.42 to -0.08
|
-0.33 cohens d
Interval -0.63 to -0.04
|
-0.19 cohens d
Interval -0.42 to 0.04
|
-0.27 cohens d
Interval -0.57 to 0.03
|
-0.36 cohens d
Interval -0.55 to -0.16
|
-0.04 cohens d
Interval -0.17 to 0.09
|
-0.29 cohens d
Interval -0.45 to -0.13
|
-0.54 cohens d
Interval -0.81 to -0.27
|
-0.10 cohens d
Interval -0.38 to 0.18
|
-0.42 cohens d
Interval -0.61 to -0.23
|
-0.25 cohens d
Interval -0.54 to -0.03
|
-0.10 cohens d
Interval -0.29 to 0.09
|
-0.08 cohens d
Interval -0.26 to 0.1
|
PRIMARY outcome
Timeframe: Prior to intranasal insulin administration relative to 30 minutes followingThe effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy
|
-0.26 cohens d
Interval -0.74 to 0.23
|
-0.12 cohens d
Interval -0.51 to 0.28
|
0.06 cohens d
Interval -0.18 to 0.29
|
-0.01 cohens d
Interval -0.25 to 0.23
|
0.01 cohens d
Interval -0.26 to 0.27
|
-0.13 cohens d
Interval -0.46 to 0.2
|
-0.03 cohens d
Interval -0.28 to 0.22
|
0.16 cohens d
Interval -0.17 to 0.49
|
-0.04 cohens d
Interval -0.28 to 0.21
|
-0.19 cohens d
Interval -0.4 to 0.02
|
-0.06 cohens d
Interval -0.37 to 0.26
|
-0.14 cohens d
Interval -0.46 to 0.19
|
-0.05 cohens d
Interval -0.14 to 0.05
|
0.05 cohens d
Interval -0.23 to 0.33
|
PRIMARY outcome
Timeframe: Prior to intranasal insulin administration relative to 30 minutes followingThe effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=6 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task
|
0.00 cohens d
Interval -0.08 to 0.08
|
-0.04 cohens d
Interval -0.16 to 0.09
|
0.01 cohens d
Interval -0.17 to 0.19
|
-0.03 cohens d
Interval -0.11 to 0.04
|
0.00 cohens d
Interval -0.09 to 0.1
|
0.15 cohens d
Interval 0.09 to 0.21
|
0.07 cohens d
Interval -0.04 to 0.17
|
-0.08 cohens d
Interval -0.24 to 0.08
|
-0.01 cohens d
Interval -0.12 to 0.1
|
0.00 cohens d
Interval -0.09 to 0.08
|
0.00 cohens d
Interval -0.15 to 0.15
|
-0.06 cohens d
Interval -0.2 to 0.07
|
0.00 cohens d
Interval -0.12 to 0.12
|
0.00 cohens d
Interval -0.09 to 0.09
|
PRIMARY outcome
Timeframe: Prior to intranasal insulin administration relative to 30 minutes followingThe effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=6 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task
|
-0.03 cohens d
Interval -0.37 to 0.31
|
-0.25 cohens d
Interval -0.52 to 0.02
|
-0.41 cohens d
Interval -0.98 to 0.16
|
0.12 cohens d
Interval -0.4 to 0.64
|
0.19 cohens d
Interval -0.54 to 0.93
|
0.20 cohens d
Interval -0.35 to 0.75
|
-0.22 cohens d
Interval -0.54 to 0.1
|
-0.06 cohens d
Interval -0.3 to 0.19
|
0.16 cohens d
Interval -0.14 to 0.45
|
0.15 cohens d
Interval -0.28 to 0.58
|
-0.42 cohens d
Interval -1.0 to 0.16
|
0.06 cohens d
Interval -0.14 to 0.26
|
-0.05 cohens d
Interval -0.53 to 0.42
|
-0.21 cohens d
Interval -0.4 to -0.03
|
PRIMARY outcome
Timeframe: Prior to intranasal insulin administration relative to 30 minutes followingThe effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect Size of Change in Behavioral Index of Sustained Attention - RT
|
-0.05 cohens d
Interval -0.16 to 0.07
|
-0.16 cohens d
Interval -0.54 to 0.23
|
-0.18 cohens d
Interval -0.36 to 0.01
|
-0.09 cohens d
Interval -0.26 to 0.09
|
-0.19 cohens d
Interval -0.39 to 0.0
|
-0.16 cohens d
Interval -0.37 to 0.06
|
-0.18 cohens d
Interval -0.37 to 0.0
|
-0.16 cohens d
Interval -0.25 to -0.07
|
-0.15 cohens d
Interval -0.49 to 0.19
|
-0.24 cohens d
Interval -0.54 to 0.06
|
-0.20 cohens d
Interval -0.36 to -0.03
|
-0.22 cohens d
Interval -0.37 to -0.07
|
-0.11 cohens d
Interval -0.37 to 0.15
|
-0.16 cohens d
Interval -0.29 to -0.03
|
PRIMARY outcome
Timeframe: Prior to intranasal insulin administration relative to 30 minutes followingThe effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy
|
0.36 cohens d
Interval -0.07 to 0.8
|
-0.21 cohens d
Interval -1.23 to 0.8
|
0.78 cohens d
Interval 0.23 to 1.32
|
0.43 cohens d
Interval -0.12 to 0.98
|
0.90 cohens d
Interval 0.33 to 1.48
|
0.60 cohens d
Interval -0.23 to 1.44
|
0.69 cohens d
Interval 0.19 to 1.2
|
0.81 cohens d
Interval -0.1 to 1.73
|
0.05 cohens d
Interval -0.51 to 0.62
|
0.87 cohens d
Interval 0.4 to 1.35
|
0.62 cohens d
Interval 0.03 to 1.2
|
0.71 cohens d
Interval 0.1 to 1.32
|
0.69 cohens d
Interval -0.13 to 1.51
|
0.54 cohens d
Interval 0.06 to 1.02
|
PRIMARY outcome
Timeframe: Prior to intranasal insulin administration relative to 30 minutes followingThe effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=6 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task
|
0.02 cohens d
Interval -0.18 to 0.22
|
0.02 cohens d
Interval -0.15 to 0.2
|
0.18 cohens d
Interval 0.0 to 0.36
|
0.04 cohens d
Interval -0.25 to 0.33
|
-0.03 cohens d
Interval -0.19 to 0.14
|
-0.06 cohens d
Interval -0.35 to 0.24
|
-0.02 cohens d
Interval -0.27 to 0.23
|
-0.09 cohens d
Interval -0.21 to 0.03
|
0.04 cohens d
Interval -0.2 to 0.29
|
0.23 cohens d
Interval 0.02 to 0.45
|
0.02 cohens d
Interval -0.17 to 0.21
|
0.16 cohens d
Interval 0.03 to 0.28
|
0.08 cohens d
Interval -0.15 to 0.31
|
0.03 cohens d
Interval -0.17 to 0.24
|
PRIMARY outcome
Timeframe: Prior to intranasal insulin administration relative to 30 minutes followingThe effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Outcome measures
| Measure |
Acute Exercise - 20 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=6 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=7 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - Placebo
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 Participants
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=8 Participants
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task
|
0.34 cohens d
Interval -0.15 to 0.83
|
0.00 cohens d
Interval -0.22 to 0.21
|
0.04 cohens d
Interval -0.3 to 0.37
|
0.05 cohens d
Interval -0.3 to 0.4
|
0.10 cohens d
Interval -0.36 to 0.57
|
0.05 cohens d
Interval -0.37 to 0.47
|
0.08 cohens d
Interval -0.32 to 0.48
|
-0.06 cohens d
Interval -0.26 to 0.14
|
-0.08 cohens d
Interval -0.77 to 0.61
|
-0.09 cohens d
Interval -0.29 to 0.11
|
0.26 cohens d
Interval -0.43 to 0.96
|
0.25 cohens d
Interval -0.36 to 0.86
|
-0.10 cohens d
Interval -0.48 to 0.29
|
-0.03 cohens d
Interval -0.33 to 0.27
|
Adverse Events
Passive Control - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Control - 20 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Control - 40 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Control - 60 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Control - 80 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Control - 100 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Control - 120 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Exercise - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Acute Exercise - 20 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Exercise - 40 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Exercise - 60 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Exercise - 80 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Exercise - 100 IU
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Acute Exercise - 120 IU
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Passive Control - Placebo
n=8 participants at risk
20 minute sedentary control period during which participants watched an emotionally neutral video.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 20 IU
n=8 participants at risk
20 minute sedentary control period during which participants watched an emotionally neutral video.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 40 IU
n=9 participants at risk
20 minute sedentary control period during which participants watched an emotionally neutral video.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 60 IU
n=8 participants at risk
20 minute sedentary control period during which participants watched an emotionally neutral video.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 80 IU
n=8 participants at risk
20 minute sedentary control period during which participants watched an emotionally neutral video.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 100 IU
n=9 participants at risk
20 minute sedentary control period during which participants watched an emotionally neutral video.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Passive Control - 120 IU
n=8 participants at risk
20 minute sedentary control period during which participants watched an emotionally neutral video.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - Placebo
n=10 participants at risk
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 20 IU
n=8 participants at risk
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 40 IU
n=8 participants at risk
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 60 IU
n=7 participants at risk
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 80 IU
n=7 participants at risk
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 100 IU
n=9 participants at risk
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
Acute Exercise - 120 IU
n=9 participants at risk
20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.
120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemic event
|
0.00%
0/8 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/8 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/9 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/8 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/8 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/9 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/8 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
10.0%
1/10 • Number of events 1 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/8 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/8 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/7 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
0.00%
0/7 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
11.1%
1/9 • Number of events 1 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
22.2%
2/9 • Number of events 2 • Only during the two 90 minute sessions.
The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place