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CompletedNCT02530827Updated Aug 21, 2015

Energy Expenditure of People Living With HIV/AIDS

An observational study in HIV/AIDS and HIV Lipodystrophy Syndrome, sponsored by University of Sao Paulo General Hospital. Completed. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-08-21.

Sponsored by University of Sao Paulo General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
45
Ages
18 Years to 60 Years
Sex
Male
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Study 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.

Read the 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).

02

Conditions studied

  • HIV/AIDS
  • HIV Lipodystrophy Syndrome

Keywords

  • energy expenditure
  • doubly labeled water
  • accelerometer
  • HIV
  • lipodystrophy syndrome.
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 45 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Men previously diagnosed with HIV infection, on antiretroviral therapy.

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

Exclusion Criteria:

  • Signs or symptoms of opportunistic infections
  • Thyroid disease
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
45 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

Interventions

  • Druguse 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.

    Also known as: statins and fibrates

06

What researchers measure

Primary outcomes

  1. Total Energy Expenditure (kcal/d)

    Time frame: 14 day

  2. Resting Energy Expenditure (kcal/d)

    Time frame: 1 day

Secondary outcomes

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

    Time frame: 14 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02530827
Lead sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Sponsor
First posted
Aug 21, 2015
Start date
Mar 2013
Primary completion
Jun 2014
Completion
Nov 2014
Last update
Aug 21, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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