Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome

Not Applicable

Completed

• Conditions: HIV Infections; Metabolic Syndrome; HIV (Human Immunodeficiency Virus)
• Interventions: Behavioral: Dietary Intervention

• Registration Number: NCT00857298
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced weight loss. The investigators hypothesize that health markers will improve in both groups but that the improvement will be blunted in the women with HIV-MS.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-13
• Last Update Posted: 2015-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Sedentary
• Obese
• Have either dyslipidemia (HDL < 50 or triglycerides > 150), waist circumference > 88cm, and impaired glucose tolerance or homeostasis model assessment value of > 3
• Subjects with HIV-MS must have been receiving HAART for > 6 months

Exclusion Criteria

• Medication changes in the last 3 months
• Diabetes mellitus
• Medical problems that in the opinion of the principal investigator may interfere with patient safety
• Substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV-MS	Dietary Intervention	HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
MS only	Dietary Intervention	HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight

Primary Outcome Measures

Name	Time	Method
Effect of weight loss on body composition	three months
Effect of weight loss on insulin action	three months

Secondary Outcome Measures

Name	Time	Method
Effect of weight loss on adipose tissue distribution	three months
Effect of weight loss intrahepatic triglyceride content	three months
Effect of weight loss on insulin action adipose tissue	three months
Effect of weight loss on body fat mass	three months
Effect of weight loss on insulin action in liver	three months
Effect of weight loss on insulin action in skeletal muscle	three months

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States