Trial Outcomes & Findings for Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes (NCT NCT01206322)
NCT ID: NCT01206322
Last Updated: 2019-06-26
Results Overview
To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score). Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg). Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order. Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo.
COMPLETED
PHASE2
30 participants
Acute changes within 2 hours
2019-06-26
Participant Flow
Thirty consented subjects, 15 type 2 diabetic and 14 controls completed the protocol. One control was excluded after starting the study. Screened participants that did not start study: 27 were excluded after screening visit, 7 withdrew consent. Enrollment Table list the characteristics of 29 participants who completed the protocol.
Participant milestones
| Measure |
Diabetes Group: Placebo First
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo
|
Diabetes Group: Insulin First
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo
|
Control Group: Placebo First
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo
|
Control Group: Insulin First
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
11
|
9
|
6
|
|
Overall Study
COMPLETED
|
4
|
11
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Diabetes Group: Placebo First
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo
|
Diabetes Group: Insulin First
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo
|
Control Group: Placebo First
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo
|
Control Group: Insulin First
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Healthy
n=14 Participants
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order.
|
Diabetics
n=15 Participants
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Acute changes within 2 hoursTo determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score). Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg). Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order. Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo.
Outcome measures
| Measure |
Diabetes Group: Placebo
n=15 Participants
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
|
Diabetes Group: Insulin
n=15 Participants
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
|
Control Group: Placebo
n=14 Participants
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
|
Control Group: Insulin
n=14 Participants
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
|
|---|---|---|---|---|
|
Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score)
|
39.46 T-score
Standard Deviation 8.86
|
41.23 T-score
Standard Deviation 9.85
|
43.1 T-score
Standard Deviation 17.29
|
50.9 T-score
Standard Deviation 9.66
|
PRIMARY outcome
Timeframe: Acute changes within 2 hoursTo determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score). Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg).
Outcome measures
| Measure |
Diabetes Group: Placebo
n=15 Participants
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
|
Diabetes Group: Insulin
n=15 Participants
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
|
Control Group: Placebo
n=14 Participants
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
|
Control Group: Insulin
n=14 Participants
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
|
|---|---|---|---|---|
|
Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg)
|
39.2 ml/100g/min/mmHg
Standard Deviation 3.3
|
46.4 ml/100g/min/mmHg
Standard Deviation 3.6
|
40.3 ml/100g/min/mmHg
Standard Deviation 2.4
|
36.9 ml/100g/min/mmHg
Standard Deviation 2.5
|
Adverse Events
Diabetes Group: Placebo
Diabetes Group: Insulin
Control Group: Placebo
Control Group: Insulin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diabetes Group: Placebo
n=15 participants at risk
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.
The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants.
|
Diabetes Group: Insulin
n=15 participants at risk
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.
The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants.
|
Control Group: Placebo
n=15 participants at risk
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.
The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants.
|
Control Group: Insulin
n=15 participants at risk
Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.
The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants.
|
|---|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place