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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00857298
Other study ID # HW-08-0628
Secondary ID
Status Completed
Phase N/A
First received March 4, 2009
Last updated February 13, 2015
Start date February 2009
Est. completion date July 2014

Study information

Verified date February 2015
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of weight loss on body composition three months No
Primary Effect of weight loss on insulin action three months No
Secondary Effect of weight loss on body fat mass three months No
Secondary Effect of weight loss on adipose tissue distribution three months No
Secondary Effect of weight loss intrahepatic triglyceride content three months No
Secondary Effect of weight loss on insulin action adipose tissue three months No
Secondary Effect of weight loss on insulin action in liver three months No
Secondary Effect of weight loss on insulin action in skeletal muscle three months No
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