Trial Outcomes & Findings for Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome (NCT NCT00362440)
NCT ID: NCT00362440
Last Updated: 2017-03-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
At the end of each 3 month intervention
Results posted on
2017-03-23
Participant Flow
Participant milestones
| Measure |
Leptin
Leptin replacement therapy
Leptin+pioglitazone
|
Pioglitazone or Metformin
Diabetes treatment therapy
Pioglitazone+placebo
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Leptin
n=5 Participants
Leptin replacement therapy
Leptin+pioglitazone
|
Pioglitazone or Metformin
n=4 Participants
Diabetes treatment therapy
Pioglitazone+placebo
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
50 years
n=39 Participants
|
50 years
n=41 Participants
|
50 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=39 Participants
|
4 participants
n=41 Participants
|
9 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: At the end of each 3 month interventionOutcome measures
| Measure |
Leptin
n=5 Participants
Leptin replacement therapy
Leptin+pioglitazone
|
Pioglitazone or Metformin
n=4 Participants
Diabetes treatment therapy
Pioglitazone+placebo
|
|---|---|---|
|
Insulin Resistance (HOMA Index)
|
1.6 units on a scale
Standard Error 0.5
|
1.8 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: At the end of each 3 month interventionOutcome measures
| Measure |
Leptin
n=5 Participants
Leptin replacement therapy
Leptin+pioglitazone
|
Pioglitazone or Metformin
n=4 Participants
Diabetes treatment therapy
Pioglitazone+placebo
|
|---|---|---|
|
Cholesterol Levels
|
190 mg/dl
Standard Error 13
|
183 mg/dl
Standard Error 17
|
SECONDARY outcome
Timeframe: At the end of each 3 month interventionOutcome measures
| Measure |
Leptin
n=5 Participants
Leptin replacement therapy
Leptin+pioglitazone
|
Pioglitazone or Metformin
n=4 Participants
Diabetes treatment therapy
Pioglitazone+placebo
|
|---|---|---|
|
Body Composition (Fat Mass)
|
16.7 kg
Standard Error 1.7
|
13.1 kg
Standard Error 0.8
|
Adverse Events
Leptin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pioglitazone or Metformin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Leptin
n=5 participants at risk
Leptin replacement therapy
Leptin+pioglitazone
|
Pioglitazone or Metformin
n=4 participants at risk
Diabetes treatment therapy
Pioglitazone+placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
20.0%
1/5 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place