Trial Outcomes & Findings for Treating the Endothelium to Restore Insulin Sensitivity (NCT NCT00402194)
NCT ID: NCT00402194
Last Updated: 2013-09-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
3 months
Results posted on
2013-09-24
Participant Flow
Subjects were recruited by word of mouth and flyers posted in key locations on campus.
Participant milestones
| Measure |
Treatment
Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
|
Placebo
Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating the Endothelium to Restore Insulin Sensitivity
Baseline characteristics by cohort
| Measure |
Treatment
n=9 Participants
Treatment with 100mg of losartan daily or placebo. Outcomes measured before and after 3 months of treatment.
|
Placebo
n=8 Participants
Placebo
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
41.0 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Treatment
n=9 Participants
Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
|
Placebo
n=8 Participants
Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
|
|---|---|---|
|
Leg Blood Flow Response to Insulin
Baseline Leg Blood Flow
|
0.24 Liters/minute
Standard Deviation 0.05
|
0.26 Liters/minute
Standard Deviation 0.05
|
|
Leg Blood Flow Response to Insulin
Insulin stimulated leg blood flow
|
0.353 Liters/minute
Standard Deviation 0.327
|
0.046 Liters/minute
Standard Deviation 0.049
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Treatment
n=9 Participants
Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
|
Placebo
n=8 Participants
Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
|
|---|---|---|
|
Insulin-stimulated Leg Glucose Uptake
|
0.42 mmol/min
Standard Deviation 0.08
|
0.30 mmol/min
Standard Deviation 0.09
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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