Trial Outcomes & Findings for The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes (NCT NCT03379792)
NCT ID: NCT03379792
Last Updated: 2024-01-05
Results Overview
Measured via whole room calorimetry; based on oxygen consumption and carbon dioxide production measured using gas analyzers, as well as 14-hour urinary nitrogen excretion; calculated using established equations.
Recruitment status
COMPLETED
Target enrollment
32 participants
Primary outcome timeframe
24 hours
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
Type 1 Diabetes: BMI Classified as Lean
Participants with type 1 diabetes who had a BMI between 18.0-24.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Overweight
Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Obese
Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
Control: BMI Classified as Lean
Control participants without diabetes with a BMI between 18.0-24.9 kg/m\^2.
|
Control: BMI Classified as Overweight
Control participants without diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Control: BMI Classified as Obese
Control participants without diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
5
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
6
|
9
|
5
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Type 1 Diabetes: BMI Classified as Lean
Participants with type 1 diabetes who had a BMI between 18.0-24.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Overweight
Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Obese
Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
Control: BMI Classified as Lean
Control participants without diabetes with a BMI between 18.0-24.9 kg/m\^2.
|
Control: BMI Classified as Overweight
Control participants without diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Control: BMI Classified as Obese
Control participants without diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Type 1 Diabetes: BMI Classified as Lean
n=6 Participants
Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Overweight
n=9 Participants
Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Obese
n=5 Participants
Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
Control: BMI Classified as Lean
n=4 Participants
Control participants without diabetes with a BMI between 18.0-24.9 kg/m\^2.
|
Control: BMI Classified as Overweight
n=4 Participants
Control participants without diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Control: BMI Classified as Obese
n=4 Participants
Control participants without diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
22.1 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
24.6 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
25.8 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
24.0 years
STANDARD_DEVIATION 2.1 • n=21 Participants
|
27.8 years
STANDARD_DEVIATION 6.1 • n=10 Participants
|
24.6 years
STANDARD_DEVIATION 3.6 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 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=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=10 Participants
|
32 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 24 hoursMeasured via whole room calorimetry; based on oxygen consumption and carbon dioxide production measured using gas analyzers, as well as 14-hour urinary nitrogen excretion; calculated using established equations.
Outcome measures
| Measure |
Type 1 Diabetes: BMI Classified as Lean
n=6 Participants
Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Overweight
n=9 Participants
Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Obese
n=5 Participants
Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
Control: BMI Classified as Lean
n=3 Participants
Control participants without diabetes with a BMI between 18.0-24.9 kg/m\^2.
|
Control: BMI Classified as Overweight
n=3 Participants
Control participants without diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Control: BMI Classified as Obese
n=3 Participants
Control participants without diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
|---|---|---|---|---|---|---|
|
Energy Expenditure
|
1978.3 Kilocalories
Standard Deviation 337.8
|
1969.8 Kilocalories
Standard Deviation 236.3
|
2414.8 Kilocalories
Standard Deviation 419.1
|
1497.7 Kilocalories
Standard Deviation 123.6
|
1902.0 Kilocalories
Standard Deviation 406.0
|
2671.3 Kilocalories
Standard Deviation 402.7
|
Adverse Events
Type 1 Diabetes: BMI Classified as Lean
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Type 1 Diabetes: BMI Classified as Overweight
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Type 1 Diabetes: BMI Classified as Obese
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control: BMI Classified as Lean
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control: BMI Classified as Overweight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control: BMI Classified as Obese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Type 1 Diabetes: BMI Classified as Lean
n=6 participants at risk
Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Overweight
n=9 participants at risk
Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Type 1 Diabetes: BMI Classified as Obese
n=5 participants at risk
Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
Control: BMI Classified as Lean
n=4 participants at risk
Control participants without diabetes with a BMI between 18.0-24.9 kg/m\^2.
|
Control: BMI Classified as Overweight
n=4 participants at risk
Control participants without diabetes with a BMI between 25.0-29.9 kg/m\^2.
|
Control: BMI Classified as Obese
n=4 participants at risk
Control participants without diabetes with a BMI between 30.0-39.9 kg/m\^2.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/6 • 28-42 days
|
11.1%
1/9 • Number of events 1 • 28-42 days
|
0.00%
0/5 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • 28-42 days
|
11.1%
1/9 • Number of events 1 • 28-42 days
|
0.00%
0/5 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • 28-42 days
|
22.2%
2/9 • Number of events 2 • 28-42 days
|
0.00%
0/5 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 28-42 days
|
0.00%
0/9 • 28-42 days
|
20.0%
1/5 • Number of events 1 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/6 • 28-42 days
|
0.00%
0/9 • 28-42 days
|
20.0%
1/5 • Number of events 1 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 28-42 days
|
11.1%
1/9 • Number of events 1 • 28-42 days
|
20.0%
1/5 • Number of events 1 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
0.00%
0/4 • 28-42 days
|
Additional Information
Richard E. Pratley
AdventHealth Translational Research Institute
Phone: 407-303-2519
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place