Clinical Trials

MainTitle

Energy Expenditure of People Living With HIV/AIDS

This study has been completed
Sponsor
University of Sao Paulo General Hospital

Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo

Information provided by (Responsible Party)
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier
NCT02530827

First received: August 4, 2015
Last updated: August 20, 2015
Last Verified: August 2015
History of Changes
Purpose

Purpose

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 Intervention
HIV/AIDS
HIV Lipodystrophy Syndrome

Drug : use of lipid-lowering drugs.

Study Type: Observational
Study Design: 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

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures

  • Total Energy Expenditure (kcal/d) [ Time Frame: 14 day ]
  • Resting Energy Expenditure (kcal/d) [ Time Frame: 1 day ]
Secondary Outcome Measures:
  • Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI) [ Time Frame: 14 days ]

Biospecimen Retention: Samples With DNA
urine.

Enrollment: 45
Study Start Date: March 2013
Study Completion Date: November 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: statins and fibrates

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).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  
Sampling Method: Probability Sample  

Study Population

Men previously diagnosed with HIV infection, on antiretroviral therapy.

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT02530827

Sponsors and Collaborators

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

More Information


Responsible Party: University of Sao Paulo General Hospital  
ClinicalTrials.gov Identifier: NCT02530827   History of Changes  
Other Study ID Numbers: CAAE 01848612.1.0000.5440  
Study First Received: August 4, 2015  
Last Updated: August 20, 2015  

Keywords provided by University of Sao Paulo General Hospital:

energy expenditure
doubly labeled water
accelerometer
HIV
lipodystrophy syndrome.

Additional relevant MeSH terms:
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Hypolipidemic Agents

ClinicalTrials.gov processed this data on December 12, 2017
This information is provided by ClinicalTrials.gov.