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
  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:


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 2014
Estimated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 9, 2013
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
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014