CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Metformin +2 moredrug
Likely dose
Metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00399360
NCT00399360N/ACompleted

Strategies for the Treatment of HIV Associated Metabolic Syndrome

Massachusetts General Hospital·interventional·Posted Nov 14, 2006·Updated Sep 14, 2012

In Brief

A clinical study evaluating Metformin, Placebo, and 1 other intervention for HIV Infections and Metabolic Syndrome X. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2006
Enrollment StartDec 1, 2006
Primary CompletionJun 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.6 years ago

Interventions

Metformindrug

Starting at 500 mg twice daily and increasing to 850 mg twice daily after 3 Months

Placebodrug

500 mg twice daily increasing to 850 mg twice daily after 3 Months

Lifestyle Modificationbehavioral

Lifestyle Modification