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

NCT00264251 | Completed DMC

• 1 other identifier: SLRHC 02-117
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. 1.Diet + exercise program.
2. 2.Rosiglitazone treatment.
3. 3.A combination treatment of diet + exercise program and rosiglitazone.

Conditions

HIV Infections; Insulin Resistance; Obesity

Keywords

HIV; Body composition; Weight reduction; Insulin resistance/sensitivity; Exercise; Diet; Visceral adiposity

Outcome Measures

Primary Outcomes (2)

• Insulin sensitivity

• Body composition

Secondary Outcomes (4)

• Quality of life

• Strength and fitness

• Lipid profile

• Additional cardiovascular risk indicators

Interventions

Weight loss through diet and exercise BEHAVIORAL

Rosiglitazone insulin sensitizing agent DRUG

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

HIV Infections; Insulin Resistance; Obesity; Weight Loss; Hypersensitivity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2005
• First Posted: December 12, 2005
• Study Start: July 1, 2005
• Study Completion: August 1, 2007
• Last Updated: October 29, 2007

Record last verified: 2007-10

Locations

US (1)