Trial Outcomes & Findings for Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome (NCT NCT00140244)
NCT ID: NCT00140244
Last Updated: 2017-05-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
At the end of each two month intervention
Results posted on
2017-05-11
Participant Flow
Participant milestones
| Measure |
r-MetHuLeptin First, Then Placebo
r-MetHuLeptin subcutaneously once daily first, then Placebo both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo First, Then r-metHuLeptin
Subcutaneously once daily Placebo first, then r-metHuLeptin both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Intervention 1
STARTED
|
3
|
4
|
|
Intervention 1
COMPLETED
|
3
|
4
|
|
Intervention 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
3
|
4
|
|
Washout
COMPLETED
|
3
|
4
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Intervention 2
STARTED
|
3
|
4
|
|
Intervention 2
COMPLETED
|
3
|
2
|
|
Intervention 2
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
All Study Participants
n=7 Participants
r-MetHuLeptin SubQ once daily
r-metHuLeptin/placebo then placebo/r-metHuLeptin
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Body mass index
|
22.2 kg/m^2
STANDARD_DEVIATION 0.83 • n=5 Participants
|
|
Fasting leptin concentration
|
1.34 ng/ml
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
triglycerides
|
530 mg/dl
STANDARD_DEVIATION 53.8 • n=5 Participants
|
|
insulin
|
11.5 micro international units(μIU)/ml
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
glucose
|
81.1 mg/dl
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
hemoglobin A1c
|
5.1 %
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
CD4 count
|
454 cells/μl
STANDARD_DEVIATION 94 • n=5 Participants
|
|
HIV viral load
|
24524 copies/ml
STANDARD_DEVIATION 13693 • n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Serum Lipid Levels
total cholesterol
|
228.8 mg/dl
Standard Error 13.3
|
219.7 mg/dl
Standard Error 13.1
|
|
Serum Lipid Levels
low density lipoprotein cholesterol
|
113.0 mg/dl
Standard Error 12.7
|
105.7 mg/dl
Standard Error 3.33
|
|
Serum Lipid Levels
triglycerides
|
409.0 mg/dl
Standard Error 88.8
|
520.5 mg/dl
Standard Error 91.1
|
|
Serum Lipid Levels
high density lipoprotein cholesterols
|
35 mg/dl
Standard Error 2.23
|
29.96 mg/dl
Standard Error 2.25
|
|
Serum Lipid Levels
Free fatty acids
|
0.45 mg/dl
Standard Error 0.07
|
0.61 mg/dl
Standard Error 0.09
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Insulin Resistance (as Assessed by HOMA-IR)
|
2.52 units on a scale
Standard Error 0.91
|
4.56 units on a scale
Standard Error 1.43
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Glycemia (as Assessed by Fasting Glucose)
|
91 mg/dl
Standard Error 2.28
|
95.6 mg/dl
Standard Error 2.8
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Low Density Lipoprotein (LDL) Cholesterol Levels
|
113 mg/dl
Standard Error 12.7
|
105.7 mg/dl
Standard Error 3.33
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Free Fatty Acid (FFA) Levels
|
0.45 mEq/liter
Standard Error 0.07
|
0.61 mEq/liter
Standard Error 0.09
|
SECONDARY outcome
Timeframe: At the end of each two month interventionpercent change in mean blood pressure
Outcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Blood Pressure
|
3.2 percentage change of mean blood pressure
Standard Error 5.7
|
-6.7 percentage change of mean blood pressure
Standard Error 6.4
|
SECONDARY outcome
Timeframe: At the end of each two month interventionFibrinogen
Outcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Fibrinogen
|
252.2 mg/dL
Standard Error 16.3
|
294.4 mg/dL
Standard Error 14.58
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Insulin Levels
|
11.6 mcIU/ml
Standard Error 4.46
|
20.3 mcIU/ml
Standard Error 7.04
|
SECONDARY outcome
Timeframe: At the end of each two month interventionlean body mass
Outcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Lean Body Mass
|
58.6 kg
Standard Error 4.41
|
61.6 kg
Standard Error 4.26
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Viral Load
|
11345 copies/ml
Standard Error 10596
|
12367 copies/ml
Standard Error 11861
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
CD4+ Lymphocytes
|
556.6 cells/mcl
Standard Error 135
|
637.2 cells/mcl
Standard Error 158.4
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Interleukin-6 (IL-6) Levels
|
1.65 pg/ml
Standard Error 0.38
|
2.14 pg/ml
Standard Error 0.53
|
SECONDARY outcome
Timeframe: At the end of each two month interventionOutcome measures
| Measure |
r-MetHuLeptin
n=5 Participants
r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
Placebo
n=7 Participants
Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
|
|---|---|---|
|
Hepatic Fat Content
|
4.02 percentage of liver volume
Standard Error 3.15
|
4.01 percentage of liver volume
Standard Error 2.65
|
Adverse Events
r-MetHuLeptin
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