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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00857298

Enrollment

Registered

2009-03-06

Start date

2009-02-28

Completion date

2014-07-31

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HIV, Metabolic Syndrome, Obesity, Treatment Experienced

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.

Interventions

BEHAVIORALDietary 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Effect of weight loss on body composition	three months
Effect of weight loss on insulin action	three months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026