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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
HIV (Human Immunodeficiency Virus); Metabolic Syndrome; HIV Infections	Behavioral: Dietary Intervention	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
Study Start Date :	February 2009
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	July 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: HIV-MS; HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight	Behavioral: 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.
Active Comparator: MS only; HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight	Behavioral: 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.

Outcome Measures

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Primary Outcome Measures :

1. Effect of weight loss on body composition [ Time Frame: three months ]
2. Effect of weight loss on insulin action [ Time Frame: three months ]

Secondary Outcome Measures :

1. Effect of weight loss on body fat mass [ Time Frame: three months ]
2. Effect of weight loss on adipose tissue distribution [ Time Frame: three months ]
3. Effect of weight loss intrahepatic triglyceride content [ Time Frame: three months ]
4. Effect of weight loss on insulin action adipose tissue [ Time Frame: three months ]
5. Effect of weight loss on insulin action in liver [ Time Frame: three months ]
6. Effect of weight loss on insulin action in skeletal muscle [ Time Frame: three months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:	Dominic Reeds, MD	Washington University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00857298 History of Changes
Other Study ID Numbers:	HW-08-0628
First Posted:	March 6, 2009
Last Update Posted:	February 16, 2015
Last Verified:	February 2015

Keywords provided by Washington University School of Medicine:

HIV; Metabolic Syndrome; Obesity; Treatment Experienced

Additional relevant MeSH terms:

Syndrome; HIV Infections; Weight Loss; Metabolic Syndrome X; Immunologic Deficiency Syndromes; Acquired Immunodeficiency Syndrome; Disease; Pathologic Processes; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases	Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immune System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Slow Virus Diseases