search
Back to results

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

Primary Purpose

HIV (Human Immunodeficiency Virus), Metabolic Syndrome, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV (Human Immunodeficiency Virus) focused on measuring HIV, Metabolic Syndrome, Obesity, Treatment Experienced

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HIV-MS

MS only

Arm Description

HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight

HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight

Outcomes

Primary Outcome Measures

Effect of weight loss on body composition
Effect of weight loss on insulin action

Secondary Outcome Measures

Effect of weight loss on body fat mass
Effect of weight loss on adipose tissue distribution
Effect of weight loss intrahepatic triglyceride content
Effect of weight loss on insulin action adipose tissue
Effect of weight loss on insulin action in liver
Effect of weight loss on insulin action in skeletal muscle

Full Information

First Posted
March 4, 2009
Last Updated
February 13, 2015
Sponsor
Washington University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00857298
Brief Title
Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
Official Title
Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV (Human Immunodeficiency Virus), Metabolic Syndrome, HIV Infections
Keywords
HIV, Metabolic Syndrome, Obesity, Treatment Experienced

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV-MS
Arm Type
Active Comparator
Arm Description
HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
Arm Title
MS only
Arm Type
Active Comparator
Arm Description
HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
Intervention Type
Behavioral
Intervention Name(s)
Dietary Intervention
Intervention Description
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 Outcome Measure Information:
Title
Effect of weight loss on body composition
Time Frame
three months
Title
Effect of weight loss on insulin action
Time Frame
three months
Secondary Outcome Measure Information:
Title
Effect of weight loss on body fat mass
Time Frame
three months
Title
Effect of weight loss on adipose tissue distribution
Time Frame
three months
Title
Effect of weight loss intrahepatic triglyceride content
Time Frame
three months
Title
Effect of weight loss on insulin action adipose tissue
Time Frame
three months
Title
Effect of weight loss on insulin action in liver
Time Frame
three months
Title
Effect of weight loss on insulin action in skeletal muscle
Time Frame
three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Reeds, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28245099
Citation
Reeds DN, Pietka TA, Yarasheski KE, Cade WT, Patterson BW, Okunade A, Abumrad NA, Klein S. HIV infection does not prevent the metabolic benefits of diet-induced weight loss in women with obesity. Obesity (Silver Spring). 2017 Apr;25(4):682-688. doi: 10.1002/oby.21793. Epub 2017 Feb 28.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs