Status:
COMPLETED
Diet, Exercise and/or Rosiglitazone for HIV-Associated Insulin Resistance
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Conditions:
HIV Infections
Insulin Resistance
Eligibility:
All Genders
20-60 years
Phase:
NA
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 ...
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) w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00264251
Start Date
July 1 2005
End Date
August 1 2007
Last Update
October 29 2007
Active Locations (1)
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1
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025