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

Sponsor:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00857298

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:

Genetics Home Reference related topics: complement factor I deficiency

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

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 ]

Estimated Enrollment:	52
Study Start Date:	February 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857298

Contacts

Contact: Sherry Lassa-Claxton

314 362-7637

lassa-claxton@WUSTL.EDU

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sherry Lassa-Claxton 314-362-7637 lassa-claxton@WUSTL.EDU

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:	Dominic Reeds, M.D., 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:	June 2, 2011
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
Weight Loss
Metabolic Syndrome X
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on February 09, 2012