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NCT00461552 · ClinicalTrials.gov registry record · Phase 2
Therapeutic Approaches to HAART-Induced Lipodystrophy
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00461552: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT00461552 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00461552, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These interventions are aimed at improving the metabolic complications of HAART therapy such as elevated lipids, and insulin resistance or diabetes.
Interventions
- OTHER Placebo
- DRUG Leptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2003-01 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT00461552 record still lists
NCT00461552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00461552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00461552 about?
NCT00461552 is a clinical study titled "Therapeutic Approaches to HAART-Induced Lipodystrophy". To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fis...
What is the current status of trial NCT00461552?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2003-01. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00461552?
The interventions under investigation include: Placebo (OTHER), Leptin (DRUG).
Who is sponsoring clinical trial NCT00461552?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00461552's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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