Trial Outcomes & Findings for Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4 (NCT NCT00574340)
NCT ID: NCT00574340
Last Updated: 2019-09-12
Results Overview
A measure of the baseline arterial dilation on day 2 is compared to the post intervention measure of dilation of the brachial artery on Day 2.
COMPLETED
EARLY_PHASE1
20 participants
baseline on day 2 and ~6 hours later at end of glucose clamp period
2019-09-12
Participant Flow
Individuals were recruited to participate in a cross-over design coming in for a 2 day study with an 8 week wash out period and then returning for another 2 day study. Individuals were randomized in the order of completing the control group (day 1 euglycemia, day 2 hypoglycemia) or antecedent hypo group (day 1 hypoglycemia, day 2 hypoglycemia).
All participants completed both studies (either the control study (day 1 euglycemia, day 2 hypoglycemia) or the antecedent hypoglycemia study (day 1 hypoglycemia, day 2 hypoglycemia) in a random order with each study separated by an 8 week wash out period.
Participant milestones
| Measure |
Control Study Then Antecedent Hypoglycemia Study Group
Day 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia
|
Antecedent Hypoglycemia Group Then Control Study
Day 1 hypoglycemia, Day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, day 2 hypoglycemia
|
|---|---|---|
|
Study 1 (2 Days)
STARTED
|
10
|
10
|
|
Study 1 (2 Days)
COMPLETED
|
10
|
10
|
|
Study 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
|
Study 2 (2 Days)
STARTED
|
6
|
6
|
|
Study 2 (2 Days)
COMPLETED
|
6
|
6
|
|
Study 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline on day 2 and ~6 hours later at end of glucose clamp periodPopulation: Flow mediated dilation of the brachial artery
A measure of the baseline arterial dilation on day 2 is compared to the post intervention measure of dilation of the brachial artery on Day 2.
Outcome measures
| Measure |
Control Group
n=16 Participants
Day 1 euglycemia, day 2 hypoglycemia
Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks
|
Antecedent Hypoglycemia Group
n=16 Participants
Day 1 hypoglycemia, day 2 hypoglycemia
Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks
|
|---|---|---|
|
Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2
|
2 percentage of change
Standard Error 1
|
7 percentage of change
Standard Error 1
|
Adverse Events
Control Group- All Participants
Antecedent Hypoglycemia Group-all Participants
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