Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome

HIV Infections Clinical Trial

Official title:

Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857298
• Other study ID #: HW-08-0628
• 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

• Acquired Immunodeficiency Syndrome
• HIV (Human Immunodeficiency Virus)
• HIV Infections
• Immunologic Deficiency Syndromes
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

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