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NCT01612858 · ClinicalTrials.gov registry record · Phase 4
Metabolic Abnormalities in HIV-infected Persons
A Phase 4 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01612858: Completed Phase 4 study, sponsored by Tufts Medical Center.
NCT01612858 is a Phase 4 study that has completed, run by Tufts Medical Center. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01612858, a Phase 4 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.
Primary Outcome
Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone
Interventions
- DRUG Metformin
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT01612858 record still lists
NCT01612858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT01612858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01612858 about?
NCT01612858 is a clinical study titled "Metabolic Abnormalities in HIV-infected Persons". The purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (me...
What is the current status of trial NCT01612858?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2011-06. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01612858?
The interventions under investigation include: Metformin (DRUG), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT01612858?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01612858's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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