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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00857298
First received: March 4, 2009
Last updated: December 9, 2013
Last verified: December 2013

March 4, 2009
December 9, 2013
February 2009
July 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00857298 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • HIV (Human Immunodeficiency Virus)
  • Metabolic Syndrome
  • HIV Infections
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: HIV-MS
    HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
    Intervention: Behavioral: Dietary Intervention
  • Active Comparator: MS only
    HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
    Intervention: Behavioral: Dietary Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
52
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00857298
HW-08-0628
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Dominic Reeds, MD Washington University School of Medicine
Washington University School of Medicine
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP