NCT00857298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

5.4 years

First QC Date

March 4, 2009

Last Update Submit

February 13, 2015

Conditions

HIV (Human Immunodeficiency Virus)Metabolic SyndromeHIV Infections

Keywords

HIVMetabolic SyndromeObesityTreatment Experienced

Outcome Measures

Primary Outcomes (2)

  • Effect of weight loss on body composition

    three months

  • Effect of weight loss on insulin action

    three months

Secondary Outcomes (6)

  • Effect of weight loss on body fat mass

    three months

  • Effect of weight loss on adipose tissue distribution

    three months

  • 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 insulin action in liver

    three months

  • +1 more secondary outcomes

Study Arms (2)

HIV-MS

ACTIVE COMPARATOR

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

Behavioral: Dietary Intervention

MS only

ACTIVE COMPARATOR

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

Behavioral: Dietary Intervention

Interventions

Dietary InterventionBEHAVIORAL

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.

HIV-MSMS only

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 28245099DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMetabolic SyndromeHIV InfectionsObesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Dominic Reeds, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

US(1)