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Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
This study has been completed.
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00857298
First received: March 4, 2009
Last updated: February 13, 2015
Last verified: February 2015
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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 ]
- 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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00857298
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
| 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: | February 13, 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 |
ClinicalTrials.gov processed this record on July 27, 2017