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

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The Washington University

Status

Completed

Conditions

HIV (Human Immunodeficiency Virus)
HIV Infections
Metabolic Syndrome

Treatments

Behavioral: Dietary Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT00857298
HW-08-0628

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

HIV-MS
Active Comparator group
Description:
HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
Treatment:
Behavioral: Dietary Intervention
MS only
Active Comparator group
Description:
HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight
Treatment:
Behavioral: Dietary Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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