Energy Expenditure of People Living With HIV/AIDS

August 20, 2015 updated by: University of Sao Paulo General Hospital

Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

45

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Men previously diagnosed with HIV infection, on antiretroviral therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Energy Expenditure (kcal/d)
Time Frame: 14 day
14 day
Resting Energy Expenditure (kcal/d)
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI)
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 20, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Estimate)

August 21, 2015

Last Update Submitted That Met QC Criteria

August 20, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 01848612.1.0000.5440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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