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NCT00399360 · ClinicalTrials.gov registry record · NA
Lifestyle Modification and Metformin Use in the Treatment of HIV
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT00399360: Completed NA study, sponsored by Massachusetts General Hospital.
NCT00399360 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00399360, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
A healthy diet and exercise have improved the health of people without human immunodeficiency virus (HIV) who have Metabolic Syndrome. In this study we would like to find out if the same benefit can be seen in people with HIV and Metabolic Syndrome. Patients with Metabolic Syndrome usually have a large waist, high blood cholesterol levels, high blood pressure, and high blood sugar levels. These are risk factors, which may increase one's chance of developing heart disease and/or diabetes. The purpose of the study is to evaluate the effects of different methods of treating HIV associated Metabolic Syndrome. The groups are: 1) a lifestyle modification program plus metformin (also known as glucophage), 2) lifestyle modification plus placebo, 3) metformin alone or 4) placebo alone. The lifestyle modification program consists of nutrition and exercise sessions with the goal of improving body composition, heart health, and ways to lower the risk of developing diabetes.
Primary Outcome
Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.
Interventions
- DRUG Placebo
- DRUG Metformin
- BEHAVIORAL Lifestyle Modification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-12 |
| Est. Completion | 2012-06 |
| Phase | NA |
What the finished NCT00399360 record still lists
NCT00399360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00399360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00399360 about?
NCT00399360 is a clinical study titled "Lifestyle Modification and Metformin Use in the Treatment of HIV". A healthy diet and exercise have improved the health of people without human immunodeficiency virus (HIV) who have Metabolic Syndrome. In this study we would like to find out if the same benefit can be seen in people with HIV and Metabolic Syndrome. Patients with Metabolic Syndrome usually have a la...
What is the current status of trial NCT00399360?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2006-12. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00399360?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lifestyle Modification (BEHAVIORAL).
Who is sponsoring clinical trial NCT00399360?
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 NCT00399360's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 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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