Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT00857298 |
Recruitment Status
:
Completed
First Posted
: March 6, 2009
Last Update Posted
: February 16, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV (Human Immunodeficiency Virus) Metabolic Syndrome HIV Infections | Behavioral: Dietary Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
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 |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: HIV-MS
HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
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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.
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Active Comparator: MS only
HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
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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.
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- Effect of weight loss on body composition [ Time Frame: three months ]
- Effect of weight loss on insulin action [ Time Frame: three months ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Dominic Reeds, MD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00857298 History of Changes |
Other Study ID Numbers: |
HW-08-0628 |
First Posted: | March 6, 2009 Key Record Dates |
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 |