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NCT01511016 · ClinicalTrials.gov registry record · NA
Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome
A NA study of HIV Lipodystrophy, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01511016: Completed NA study of HIV Lipodystrophy, sponsored by Baylor College of Medicine.
NCT01511016 is a NA study of HIV Lipodystrophy that has completed, run by Baylor College of Medicine. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01511016, a NA study of HIV Lipodystrophy, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
"HIV lipodystrophy syndrome" (HLS) is characterized by loss of fat in the arms and legs, with increase in fat in the abdomen, and abnormal blood lipid levels. Persons with HLS have high risk for cardiovascular disease and diabetes mellitus and the metabolic syndrome. The investigators have previously shown that the abnormal lipid levels and lipodystrophy in HLS are associated with defective regulation of lipid metabolic rates, specifically, accelerated lipolysis (breakdown of stored fats), and decreased fat oxidation (utilization of fats for energy). Patients with HLS also have low levels of the hormone leptin. The investigators hypothesize that treatment of these patients with leptin will improve fat oxidation and may slow the rate of lipolysis. Hence, the investigators propose to study the effect of leptin therapy on lipid metabolic rates and lipid and glucose levels in adults with HLS. The investigators will use state of the art stable isotope tracer techniques and gas chromatography mass spectrometry (GCMS) to measure lipolysis, fat oxidation, and fat re-esterification in adipose tissues and liver.
Primary Outcome
Rate of total lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Human recombinant leptin ("metreleptin")
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2003-02 |
| Est. Completion | 2011-10 |
| Phase | NA |
What the finished NCT01511016 record still lists
NCT01511016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with HIV Lipodystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01511016 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01511016 about?
NCT01511016 is a clinical study titled "Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome". "HIV lipodystrophy syndrome" (HLS) is characterized by loss of fat in the arms and legs, with increase in fat in the abdomen, and abnormal blood lipid levels. Persons with HLS have high risk for cardiovascular disease and diabetes mellitus and the metabolic syndrome. The investigators have previousl...
What is the current status of trial NCT01511016?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2003-02. Estimated completion is 2011-10.
What conditions does trial NCT01511016 study?
This clinical trial studies the following conditions: HIV Lipodystrophy.
What interventions are being tested in trial NCT01511016?
The interventions under investigation include: Placebo (DRUG), Human recombinant leptin ("metreleptin") (DRUG).
Who is sponsoring clinical trial NCT01511016?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01511016 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01511016's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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