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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Luke's-Roosevelt Hospital Center
• Treatments: Insulin; Insulin, Globin Zinc; Rosiglitazone

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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