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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 is a NA study of HIV Lipodystrophy that has completed, run by Baylor College of Medicine. The registered enrollment target is 17 participants. The trial reports 1 study location across 1 state.

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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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Human recombinant leptin ("metreleptin")

Study Locations (1)

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2003-02
Est. Completion 2011-10
Phase NA

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT01511016

The ClinicalTrials.gov registry entry for NCT01511016 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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