Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances

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

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-06-30

Brief Summary

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To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently available antiretroviral drugs, and the prevalence of associated metabolic syndrome in HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the severity of fat accumulation and antiretroviral drug use.

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Detailed Description

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Cross-sectional evaluation of two groups of patients:

* patients receiving currently available drugs, in order to determine the changes in fat accumulation by successive dual X-ray absorptiometry (DXA) determinations
* patients with previous lipodystrophy syndrome, as evaluated by questionnaire (HOPS) and total body dual X-ray absorptiometry (DXA), in order to determine the prevalence of hypertension, low high density lipoprotein (HDL)-cholesterol, glucose disturbance (insulin resistance or diabetes), fat accumulation (waist circumference) and hypertriglyceridemia.

The prevalence of Metabolic syndrome will be evaluated according to the different definitions (IDF, NCEP-ATP III, WHO).

Conditions

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Lipodystrophy Metabolic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Evaluation of metabolic syndrome

Evaluation and analytical determinations of the different components of the syndrome

Intervention Type OTHER

Evaluation of changes in fat by DXA while on current therapy

Comparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV infection
* Older than 18 years
* Receiving first or second antiretroviral regimen or
* Previous evaluation and classification of lipodystrophy syndrome

Exclusion Criteria

* Pregnancy
* Diagnosis of hypothyroidism, Cushing's syndrome or prolonged intake of corticosteroids or hormones before inclusion
* Patients who had received antiretroviral drugs known to produce fat disturbances (for lipodystrophy prevalence objective)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No