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Energy Expenditure of People Living With HIV/AIDS

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02530827
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
45
Enrollment
20
Duration (Months)

Study Details

Study Description

Brief Summary

Background: Several studies have reported increased resting energy expenditure (REE) in people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV lipodystrophy syndrome.

The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive for HIV in treatment of lipodystrophy.

Condition or Disease Intervention/Treatment Phase
  • Drug: use of lipid-lowering drugs.

Detailed Description

REE was measured by indirect calorimetry.

TEE was measured by doubly labeled water (DLW) technique and an activity monitor based on accelerometry (AM).

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
LIPO-HIPO-

HIV-seropositive without lipodystrophy and no use of lipid-lowering drugs.
LIPO+HIPO-

HIV-seropositive with lipodystrophy and no use of lipid-lowering drugs.
LIPO+HIPO+

HIV-seropositive with lipodystrophy and use of lipid-lowering drugs.

Drug: use of lipid-lowering drugs.
The patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study.
Other Names:
  • statins and fibrates

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total Energy Expenditure (kcal/d) [14 day]

    2. Resting Energy Expenditure (kcal/d) [1 day]

    Secondary Outcome Measures

    1. Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI) [14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Use of antiretroviral therapy for at least 4 months

    • A cluster of differentiation 4 (CD4) T-cell count of >200 cells/mm3

    • Use of lipid-lowering drugs for at least 1 month (group HIV-seropositive with lipodystrophy and use of lipid-lowering)

    Exclusion Criteria:

    • Signs or symptoms of opportunistic infections

    • Thyroid disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital
    • Fundação de Amparo à Pesquisa do Estado de São Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT02530827
    Other Study ID Numbers:
    • CAAE 01848612.1.0000.5440
    First Posted:
    Aug 21, 2015
    Last Update Posted:
    Aug 21, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by University of Sao Paulo General Hospital
    energy expenditure
    doubly labeled water
    accelerometer
    HIV
    lipodystrophy syndrome.
    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections
    HIV-Associated Lipodystrophy Syndrome
    Lipodystrophy
    Hypolipidemic Agents

    Study Results

    No Results Posted as of Aug 21, 2015