Diet, Exercise and/or Rosiglitazone for HIV-Associated Insulin Resistance
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party)
St. Luke's-Roosevelt Hospital Center
First received: December 9, 2005
Last updated: October 26, 2007
Last Verified: October 2007
History of Changes
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:
- Diet + exercise program.
- Rosiglitazone treatment.
Behavioral : Weight loss through diet and exercise
Drug : Rosiglitazone insulin sensitizing agent
Intervention Model: Parallel Assignment
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
- Quality of life
- Strength and fitness
- Lipid profile
- Additional cardiovascular risk indicators
|Study Start Date:||July 2005|
|Study Completion Date:||August 2007|
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:
- 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.
- HIV infection decreases the changes in insulin resistance and body composition (increase in SAT and decrease in VAT) expected with rosiglitazone.
- The combination treatment of diet+exercise and rosiglitazone will reduce VAT to a
|Ages Eligible for Study:||20 Years to 60 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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).
- 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 LocationsChoosing 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 Show More
|United States, New York|
|St. Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10025|
Sponsors and CollaboratorsSt. 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|
|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
Additional relevant MeSH terms:
Insulin, Globin Zinc
ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.