Clinical Trials

MainTitle

Rosiglitazone and Exercise Training: Effects on HIV-Infected People With Insulin Resistance, Hypertriglyceridemia, and Adipose Tissue Maldistribution

This study has been completed
Sponsor
National Center for Research Resources (NCRR)

Collaborator
The Campbell Foundation

Information provided by (Responsible Party)
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier
NCT00025753

First received: October 19, 2001
Last updated: June 23, 2005
Last Verified: December 2003
History of Changes
Purpose

Purpose

Several complications have become prevalent in people living with HIV/AIDS, including increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution. The causes of these complications are not well understood and effective treatments have not been identified. We propose to test the efficacy and safety of 2 treatments for these complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone have been effective and moderately safe when used in HIV-seronegative people with diabetes, but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.

Condition Intervention
HIV Infections
Insulin Resistance

Drug : rosiglitazone (Avandia)
Behavioral : Aerobic and weight lifting exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Rosiglitazone and Exercise Training: Effects on HIV-Infected People With Insulin Resistance, Hypertriglyceridemia, and Adipose Tissue Maldistribution

Further study details as provided by National Center for Research Resources (NCRR):

Detailed Description:

We propose a 12wk controlled, randomized trial that compares the effects of rosiglitazone therapy, exercise training and combined rosiglitazone and exercise training. We hypothesize that rosiglitazone will lower blood sugar, insulin, blood fats, muscle and liver lipid content and composition in HIV-infected people. Exercise training will induce the same benefits, but will also reduce abdominal fat mass. We hypothesize that combining exercise training with rosiglitazone therapy will be most effective at reducing blood sugar, insulin, lipids, muscle and liver lipid contents, and restoring body fat distribution than either intervention alone. At baseline and after 12 wk of treatment we will measure: the ability of insulin to promote the clearance of sugar from the blood, the clearance rate of blood sugar, the rate of glucose production by the liver, blood fat and cholesterol concentrations, body fat content and fat distribution in the arms, legs, trunk regions, muscle and liver lipid content and composition.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

The research volunteers will consist of HIV-infected men and women treated with PI-based HAART who have developed insulin resistance of impaired glucose homeostasis:

  • fasting (8h) plasma glucose 110-126 mg/dL (6.1-7.1 mM) OR
  • plasma glucose >140 (7.8 mM) 2 hours after a 75g-oral glucose load.

  • Although not required for enrollment, many of these volunteers will also have developed trunk adipose tissue redistribution (defined as): trunk/appendicular adipose ratio using whole-body DEXA >1.1 (men), >0.9 (women), or visceral adipose/total abdominal adipose tissue (VAT/TAT) >0.40 using 1H-MRI imaging at the level of the umbilicus (~L3-L4 inter-vertebral space). Many will also have developed fasting hypertriglyceridemia (>300mg/dL, >3.4 mM).
  • Plasma viremia (Roche Amplicor assay) <5000 copies/ml OR a CD4 T-cell county >= 200 cells/ul for at least 3 months prior to enrollment.
  • Stable on a PI-containing HAART regimen for at least 3 months prior to enrollment.
  • 18-65 years of age
  • Body mass index <= 34kg/m*2, total body fat <=35% of weight

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: NCT00025753

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

National Center for Research Resources (NCRR)
The Campbell Foundation
More Information

More Information


Responsible Party: National Center for Research Resources (NCRR)  
ClinicalTrials.gov Identifier: NCT00025753   History of Changes  
Other Study ID Numbers: NCRR-M01RR00036-0823  
Study First Received: October 19, 2001  
Last Updated: June 23, 2005  

Additional relevant MeSH terms:
HIV Infections
Insulin Resistance
Hypertriglyceridemia
Rosiglitazone

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.