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

Obesity Clinical Trial

Official title:

Effect of Diet, Exercise and Rosiglitazone on Regional Fat and Insulin Resistance in HIV-Infected and Uninfected Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264251
• Other study ID #: SLRHC 02-117
• Status: Completed
• Phase: N/A
• First received: December 9, 2005
• Last updated: October 26, 2007
• Start date: July 2005
• Est. completion date: August 2007

Study information

• Verified date: October 2007
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

A constellation of nutritional alterations in HIV-infected patients receiving highly active antiretroviral therapies (HAART), including body fat redistribution with subcutaneous adipose tissue (SAT) wasting and visceral adipose tissue (VAT) accumulation, hyperlipidemia, and insulin resistance (IR) has been described. There is a major concern that these developments will be associated with adverse clinical outcomes related to atherosclerosis, as suggested by several case reports (Henry 1998, Behrens 1998, Gallet 1998, Vittecoq 1998). Although there are well documented associations among body fat distribution, insulin resistance, and adverse health outcomes, especially accelerated atherosclerosis, in non-HIV infected individuals, it is unclear if the relationships are affected by HIV infection, or if they reflect the same outcomes. This information is important, since understanding the interrelationships between body fat distribution and metabolism may guide the development of treatment strategies.

The specific hypotheses to be tested are:

1. HIV infection does not affect the relative reductions in visceral (VAT) and subcutaneous adipose tissue (SAT) resulting from diet + exercise, but decreases the effect of this therapy on insulin resistance.

2. HIV infection decreases the changes in insulin resistance and body composition (increase in SAT and decrease in VAT) expected with rosiglitazone.

3. The combination treatment of diet+exercise and rosiglitazone will reduce VAT to a greater extent than rosiglitazone alone, and will improve insulin resistance to greater extent than diet and exercise alone, however these effects will be blunted in HIV-infected subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Insulin Resistance
• Obesity

Intervention

Behavioral:
• Weight loss through diet and exercise

Drug:
• Rosiglitazone insulin sensitizing agent

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity
Primary	Body composition
Secondary	Quality of life
Secondary	Strength and fitness
Secondary	Lipid profile
Secondary	Additional cardiovascular risk indicators