Diet, Exercise and/or Rosiglitazone for HIV-Associated Insulin Resistance

Completed · Not applicable

Conditions studied: HIV Infections, Insulin Resistance, Obesity

In brief

The purpose of this study is to determine if, in men and women with excess abdominal fat and insulin resistance, people with HIV infection respond differently than people without HIV to interventions that typically improve body fat distribution and insulin resistance. The specific interventions are: 1. Diet + exercise program. 2. Rosiglitazone treatment. 3. A combination treatment of diet + exercise program and rosiglitazone.

Key facts

Study ID

NCT00264251

Run by

St. Luke's-Roosevelt Hospital Center

People needed

48

Starts

2005-07-01

Expected to finish

2007-08-01

Last updated by the study team

2007-10-29

Who can join

Age: 20 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• HIV-infected or uninfected.
• Body mass index (BMI) at least 25.
• Excess visceral adipose tissue. Excess VAT will be determined in HIV+ and HIV- groups of men by a waist hip ratio > 0.95 and a waist circumference >88.2 cm, and in women by a waist:hip >0.9 and waist circumference >75.3 cm.
• Insulin resistance (fasting serum insulin level >16 μU/ml).

You may not qualify if…

• Unable to tolerate magnetic resonance imaging (MRI)
• Clinical evidence of active liver disease or a significantly abnormal liver function test (ALT >2.5x the upper limit of normal).
• Severe hyperlipidemia (fasting plasma triglycerides >500 mg/dL or fasting total cholesterol >300mg/dL)
• Current coronary artery disease including angina
• Peripheral vascular disease
• Uncontrolled hypertension
• Participation in a regular exercise program

Where it is running

• St. Luke's-Roosevelt Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.