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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV (Human Immunodeficiency Virus), Metabolic Syndrome, HIV Infections

Intervention / Treatment
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* Behavioral: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV-MS<br>HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight | Behavioral: Dietary Intervention<br>* The nutrition curriculum will involve weekly group and individual sessions. The initial calorie goal will be  750 kcal below the resting energy equivalent, and adjusted as needed to achieve weight loss targets.<br>|
| Active Comparator: MS only<br>HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight | Behavioral: Dietary Intervention<br>* The nutrition curriculum will involve weekly group and individual sessions. The initial calorie goal will be  750 kcal below the resting energy equivalent, and adjusted as needed to achieve weight loss targets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of weight loss on body composition |  | three months | 
| Effect of weight loss on insulin action |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of weight loss on body fat mass |  | three months | 
| 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 insulin action in liver |  | three months | 
| Effect of weight loss on insulin action in skeletal muscle |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Metabolic Syndrome, Obesity, Treatment Experienced