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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857298
First Posted: March 6, 2009
Last Update Posted: February 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome

Resource links provided by NLM:


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 ]
  • Effect of weight loss on insulin action [ Time Frame: three months ]

Secondary Outcome Measures:
  • Effect of weight loss on body fat mass [ Time Frame: three months ]
  • Effect of weight loss on adipose tissue distribution [ Time Frame: three months ]
  • Effect of weight loss intrahepatic triglyceride content [ Time Frame: three months ]
  • Effect of weight loss on insulin action adipose tissue [ Time Frame: three months ]
  • Effect of weight loss on insulin action in liver [ Time Frame: three months ]
  • Effect of weight loss on insulin action in skeletal muscle [ Time Frame: three months ]

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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00857298     History of Changes
Other Study ID Numbers: HW-08-0628
First Submitted: March 4, 2009
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


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