Energy Expenditure of People Living With HIV/AIDS

NCT ID: NCT02530827

Last Updated: 2015-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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REE was measured by indirect calorimetry.

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

Conditions

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HIV/AIDS HIV Lipodystrophy Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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LIPO-HIPO-

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

No interventions assigned to this group

LIPO+HIPO-

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

No interventions assigned to this group

LIPO+HIPO+

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

use of lipid-lowering drugs.

Intervention Type DRUG

The patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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statins and fibrates

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CAAE 01848612.1.0000.5440

Identifier Type: -

Identifier Source: org_study_id

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