Trial · NCT01511016
Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome
NCT01511016, Not applicable, Completed, Baylor College of Medicine; results first posted 2016-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome. Trials, record NCT01511016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01511016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome
- NCT number
- NCT01511016
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 17 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- HIV Lipodystrophy
- Interventions
- Human recombinant leptin ("metreleptin"), Placebo
- First posted
- 2012-01-18
- Last updated
- 2016-01-27
- Results first posted
- 2016-01-27
- Limitations and caveats
1. Relatively small sample size.~2. Early drop-out of 3 subjects (2 in placebo arm, 2 in metreleptin arm).~3. Possible confounders in phenotypic hetereogeneity of HIV lipodystrophy, and differences in antiretroviral drugs.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Total Lipolysis | 4 months after treatment | Rate of total lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate |
| Primary | Rate of Net Lipolysis | 4 months after treatment | Rate of net lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate |
| Secondary | Rates of Fatty Acid Oxidation | 4 months after treatment | Rates of fatty acid oxidation were measured in breath samples following stable isotope infusions of 13C-labeled palmitate. |
| Secondary | Fasting Plasma Non-HDL-C | 4 months after treatment. | Fasting plasma non-HDL-cholesterol was calculated from measured total cholesterol and HDL cholesterol. |
| Secondary | Glucose Levels After Glucose Challenge | 4 months after treatment. | An oral glucose tolerance test was performed. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a standard clinical test of glucose tolerance. i.e., a test for diabetes and pre-diabetes. Although multiple time points are used in this test, the outcome is a single value, either a blood glucose level after 2 hours or an area-under-the-curve. In this study we are reporting the area-under-the-curve. |
| Secondary | Insulin Levels After Oral Glucose Challenge. | 4 months after treatment. | An oral glucose tolerance test was performed to measure endogenous insulin response. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a clinical test of endogenous insulin response to glucose i.e., an endocrine test. Although multiple time points are used in this test, the outcome is a single value, i.e., an area-under-the-curve for insulin. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Total Lipolysis | 4 months after treatment | Subjects in each group were analyzed and compared after 4 months of treatment. | mmol FFA/kg/h | MEAN |
| SECONDARY | Rates of Fatty Acid Oxidation | 4 months after treatment | Number of subjects in each group remaining at the end of 4 months of treatment. | mmol FFA/kg/h | MEAN |
| SECONDARY | Fasting Plasma Non-HDL-C | 4 months after treatment. | Number of subjects in each group remaining after 4 months of treatment. | mg/dL | MEAN |
| SECONDARY | Glucose Levels After Glucose Challenge | 4 months after treatment. | Number of subjects remaining after 4 months of treatment. | mg/dL | MEAN |
| SECONDARY | Insulin Levels After Oral Glucose Challenge. | 4 months after treatment. | Number of subjects remaining after 4 months of treatment. | microU/mL | MEAN |
| PRIMARY | Rate of Net Lipolysis | 4 months after treatment | Subjects in each group were analyzed and compared after 4 months of treatment | mmol FFA/kg/h | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Total Lipolysis | Placebo Injection | 0.649 | Standard Error 0.073 | mmol FFA/kg/h | |
| Rate of Total Lipolysis | Human Recombinant Leptin (Metreleptin) | 0.767 | Standard Error 0.137 | mmol FFA/kg/h | |
| Rates of Fatty Acid Oxidation | Placebo Injection | 0.239 | Standard Error 0.023 | mmol FFA/kg/h | |
| Rates of Fatty Acid Oxidation | Human Recombinant Leptin (Metreleptin) | 0.214 | Standard Error 0.040 | mmol FFA/kg/h | |
| Fasting Plasma Non-HDL-C | Placebo Injection | 136 | Standard Error 9 | mg/dL | |
| Fasting Plasma Non-HDL-C | Human Recombinant Leptin (Metreleptin) | 127 | Standard Error 7 | mg/dL | |
| Glucose Levels After Glucose Challenge | Placebo Injection | 6268 | Standard Error 434 | mg/dL | |
| Glucose Levels After Glucose Challenge | Human Recombinant Leptin (Metreleptin) | 6647 | Standard Error 514 | mg/dL | |
| Insulin Levels After Oral Glucose Challenge. | Placebo Injection | 1580 | Standard Error 954 | microU/mL | |
| Insulin Levels After Oral Glucose Challenge. | Human Recombinant Leptin (Metreleptin) | 2868 | Standard Error 890 | microU/mL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Injection | 8 | |
| Overall Study | STARTED | Human Recombinant Leptin (Metreleptin) | 9 | |
| Overall Study | COMPLETED | Placebo Injection | 6 | |
| Overall Study | COMPLETED | Human Recombinant Leptin (Metreleptin) | 7 | |
| Overall Study | NOT COMPLETED | Placebo Injection | 2 | |
| Overall Study | NOT COMPLETED | Human Recombinant Leptin (Metreleptin) | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hyperthyroidism | Metabolism and nutrition disorders | Placebo Injection | 1 | 8 | 1 |
| serious | Hyperthyroidism | Metabolism and nutrition disorders | Human Recombinant Leptin (Metreleptin) | 0 | 9 | 0 |
| serious | Weight loss | Metabolism and nutrition disorders | Placebo Injection | 0 | 8 | 0 |
| serious | Weight loss | Metabolism and nutrition disorders | Human Recombinant Leptin (Metreleptin) | 2 | 9 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Injection | ||
| Total, all-cause mortality | Human Recombinant Leptin (Metreleptin) | ||
| Total, other adverse events | Placebo Injection | 0 | 8 |
| Total, other adverse events | Human Recombinant Leptin (Metreleptin) | 0 | 9 |
| Total, serious adverse events | Placebo Injection | 1 | 8 |
| Total, serious adverse events | Human Recombinant Leptin (Metreleptin) | 2 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22542724 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Human Recombinant Leptin (Metreleptin) vs Placebo Injection: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01511016
GET https://conductscience.org/api/trials/v1/NCT01511016/registered