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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
St. Luke's-Roosevelt Hospital Center


Information provided by (Responsible Party)
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier
NCT00264251

First received: December 9, 2005
Last updated: October 26, 2007
Last Verified: October 2007
History of Changes
Purpose

Purpose

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.
nation treatment of diet + exercise program and rosiglitazone.

Condition Intervention
HIV Infections
Insulin Resistance
Obesity

Behavioral : Weight loss through diet and exercise
Drug : Rosiglitazone insulin sensitizing agent

Study Type: Interventional
Study Design: 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

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures

  • Insulin sensitivity
  • Body composition
Secondary Outcome Measures:
  • Quality of life
  • Strength and fitness
  • Lipid profile
  • Additional cardiovascular risk indicators

Enrollment: 48
Study Start Date: July 2005
Study Completion Date: August 2007

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.

Eligibility

Eligibility

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

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

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264251

Locations

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

Investigators

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
More Information

More Information


Responsible Party: St. Luke's-Roosevelt Hospital Center  
ClinicalTrials.gov Identifier: NCT00264251   History of Changes  
Other Study ID Numbers: SLRHC 02-117  
Study First Received: December 9, 2005  
Last Updated: October 26, 2007  

Keywords provided by St. Luke's-Roosevelt Hospital Center:

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

Additional relevant MeSH terms:
HIV Infections
Insulin Resistance
Insulin, Globin Zinc
Rosiglitazone
Insulin

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.