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

Purpose

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	Intervention
HIV (Human Immunodeficiency Virus) Metabolic Syndrome HIV Infections	Behavioral: Dietary Intervention


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines HIV/AIDS Metabolic Syndrome Obesity Weight Control

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Effect of weight loss on body composition [ Time Frame: three months ] [ Designated as safety issue: No ]
Effect of weight loss on insulin action [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of weight loss on body fat mass [ Time Frame: three months ] [ Designated as safety issue: No ]
Effect of weight loss on adipose tissue distribution [ Time Frame: three months ] [ Designated as safety issue: No ]
Effect of weight loss intrahepatic triglyceride content [ Time Frame: three months ] [ Designated as safety issue: No ]
Effect of weight loss on insulin action adipose tissue [ Time Frame: three months ] [ Designated as safety issue: No ]
Effect of weight loss on insulin action in liver [ Time Frame: three months ] [ Designated as safety issue: No ]
Effect of weight loss on insulin action in skeletal muscle [ Time Frame: three months ] [ Designated as safety issue: No ]


Enrollment:	20
Study Start Date:	February 2009
Study Completion Date:	July 2014
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00857298

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

No publications provided


Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00857298 History of Changes
Other Study ID Numbers:	HW-08-0628
Study First Received:	March 4, 2009
Last Updated:	February 13, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:


HIV Metabolic Syndrome Obesity Treatment Experienced

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 26, 2015