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NCT01405456 · ClinicalTrials.gov registry record · NA
Eplerenone in HIV Associated Abdominal Fat Accumulation
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
NCT01405456: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01405456 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 46 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01405456, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
Study Summary
The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that aldosterone, a hormone that regulates salt and water balance, is increased in association with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals, aldosterone appears to be higher in individuals with increased belly fat, and increased aldosterone appears to be strongly associated with impaired sugar metabolism. In this study, the investigators will test the effects of eplerenone, which is a medication that blocks the actions of aldosterone, along with lifestyle modification. The investigators hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce fat accumulation in liver and muscle.
Interventions
- DRUG Eplerenone and lifestyle
- OTHER placebo and lifestyle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2012-01 |
| Est. Completion | 2017-11-01 |
| Phase | NA |
What the finished NCT01405456 record still lists
NCT01405456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Eplerenone and lifestyle is the first listed.
NCT01405456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01405456 about?
NCT01405456 is a clinical study titled "Eplerenone in HIV Associated Abdominal Fat Accumulation". The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that aldosterone, a hormone that ...
What is the current status of trial NCT01405456?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2012-01. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT01405456?
The interventions under investigation include: Eplerenone and lifestyle (DRUG), placebo and lifestyle (OTHER).
Who is sponsoring clinical trial NCT01405456?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01405456's enrollment target sits among peer trials
46 1402nd of 2000 higher than 590 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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