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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-07-31

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.

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Detailed Description

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Conditions

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HIV (Human Immunodeficiency Virus) Metabolic Syndrome HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HIV-MS

HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight

Group Type ACTIVE_COMPARATOR

Dietary Intervention

Intervention Type BEHAVIORAL

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.

MS only

HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight

Group Type ACTIVE_COMPARATOR

Dietary Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Dietary Intervention

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No