Trial Outcomes & Findings for Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults (NCT NCT03520569)
NCT ID: NCT03520569
Last Updated: 2022-05-13
Results Overview
Flow mediated dilation measures the change in brachial diameter in response to 5 minutes of ischemia using B-mode ultrasound. It provides an index of nitric oxide generation by the endothelium .
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
15 participants
Primary outcome timeframe
baseline and after 2 hour insulin clamp
Results posted on
2022-05-13
Participant Flow
20 potential study participants were screened for eligibility
15 participants were ultimately enrolled. Five potential subjects failed to meet inclusion criteria and were subsequently excluded from the study.
Participant milestones
| Measure |
All Participants
All participants enrolled who completed at least one arm of the crossover assignment.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
Octreotide-Euglycemia
|
13
|
|
Overall Study
Octreotide-Euglycemia-Insulin Clamp
|
14
|
|
Overall Study
Octreotide-Hyperglycemia
|
10
|
|
Overall Study
Octreotide-Hyperglycemia-Insulin Clamp
|
12
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants
All participants enrolled who completed at least one arm of the crossover assignment.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults
Baseline characteristics by cohort
| Measure |
All Participants
n=15 Participants
all participants who completed the study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
24 years
STANDARD_DEVIATION 1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
caucasian
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
african american
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
asian
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline and after 2 hour insulin clampFlow mediated dilation measures the change in brachial diameter in response to 5 minutes of ischemia using B-mode ultrasound. It provides an index of nitric oxide generation by the endothelium .
Outcome measures
| Measure |
Octreotide- Hyperglycemia
n=10 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide- Euglycemia
n=13 Participants
octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide - Euglycemia- Insulin Clamp
n=14 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide- Hyperglycemia - Insulin Clamp
n=12 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
|---|---|---|---|---|
|
Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp
|
8.9 % change
Standard Deviation 4.3
|
11.8 % change
Standard Deviation 4.4
|
11.8 % change
Standard Deviation 4
|
8.95 % change
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: baseline and after 2 hour insulin clampThe augmentation index (AIx) measured at the radial artery is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Higher percentages indicate increased arterial stiffness.
Outcome measures
| Measure |
Octreotide- Hyperglycemia
n=10 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide- Euglycemia
n=13 Participants
octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide - Euglycemia- Insulin Clamp
n=14 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide- Hyperglycemia - Insulin Clamp
n=12 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
|---|---|---|---|---|
|
Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp
|
-4.80 percentage
Standard Deviation 12.13
|
-4.15 percentage
Standard Deviation 11.72
|
-2.23 percentage
Standard Deviation 12.33
|
-8.45 percentage
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: baseline and after 2 hour insulin clampThe time required for a blood pressure wave to travel from the carotid to the femoral artery was measured in meter/sec. This is a measurement of central artery stiffness. Higher numbers indicate stiffer vessels
Outcome measures
| Measure |
Octreotide- Hyperglycemia
n=10 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide- Euglycemia
n=13 Participants
octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide - Euglycemia- Insulin Clamp
n=14 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
Octreotide- Hyperglycemia - Insulin Clamp
n=12 Participants
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Octreotide: we are using it to block insulin secretion from the pancreas
Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solution: We are using dextrose to maintain glycemia level
|
|---|---|---|---|---|
|
Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp
|
4.79 m/sec
Standard Deviation 0.79
|
5.21 m/sec
Standard Deviation 0.64
|
5.06 m/sec
Standard Deviation 0.76
|
5.07 m/sec
Standard Deviation 0.67
|
Adverse Events
Octreotide- Euglycemia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Octreotide - Euglycemia- Insulin Clamp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Octreotide- Hyperglycemia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Octreotide- Hyperglycemia - Insulin Clamp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place