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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00264251
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : October 29, 2007
Information provided by:
St. Luke's-Roosevelt Hospital Center

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Insulin Resistance Obesity Behavioral: Weight loss through diet and exercise Drug: Rosiglitazone insulin sensitizing agent Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Diet, Exercise and Rosiglitazone on Regional Fat and Insulin Resistance in HIV-Infected and Uninfected Men and Women
Study Start Date : July 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Insulin sensitivity
  2. Body composition

Secondary Outcome Measures :
  1. Quality of life
  2. Strength and fitness
  3. Lipid profile
  4. Additional cardiovascular risk indicators

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264251

United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Principal Investigator: Donald P Kotler, MD St. Luke's-Roosevelt Hospital Center, Columbia University
Principal Investigator: Jeanine B Albu, MD St. Luke's-Roosevelt Hospital Center, Columbia University Identifier: NCT00264251     History of Changes
Other Study ID Numbers: SLRHC 02-117
First Posted: December 12, 2005    Key Record Dates
Last Update Posted: October 29, 2007
Last Verified: October 2007

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Body composition
Weight reduction
Insulin resistance/sensitivity
Visceral adiposity

Additional relevant MeSH terms:
HIV Infections
Insulin Resistance
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs