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OpenTrials
Completed

NCT Number: NCT00857298

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.

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Key information

Conditions

HIV (Human Immunodeficiency Virus) Acquired Immunodeficiency Syndrome Blood-Borne Infections Body Weight Communicable Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections Hyperinsulinism Immune System Diseases Immunologic Deficiency Syndromes Infections Insulin Resistance Lentivirus Infections Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention

Behavioral

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.

Primary outcomes

  1. Effect of weight loss on body composition

    Time frame: three months

  2. Effect of weight loss on insulin action

    Time frame: three months

Secondary outcomes

  1. Effect of weight loss on body fat mass

    Time frame: three months

  2. Effect of weight loss on adipose tissue distribution

    Time frame: three months

  3. Effect of weight loss intrahepatic triglyceride content

    Time frame: three months

  4. Effect of weight loss on insulin action adipose tissue

    Time frame: three months

  5. Effect of weight loss on insulin action in liver

    Time frame: three months

  6. Effect of weight loss on insulin action in skeletal muscle

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2009
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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