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

Study Overview
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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.

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).

Official Title
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Prevalence of Lipodystrophy Syndrome and Secondary Metabolic Syndrome in HIV-infected Patients

Conditions
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Lipodystrophy, Metabolic Syndrome

Intervention / Treatment
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* Other: Evaluation of metabolic syndrome
* Other: Evaluation of changes in fat by DXA while on current therapy


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Evaluation of metabolic syndrome|Evaluation and analytical determinations of the different components of the syndrome|
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III) | Prevalence of the different components of this syndrome: Abdominal obesity: waist circumference ≥102 cm in men and ≥88 cm in women, hypertriglyceridemia: ≥150 mg/dl (1.695 mmol/l), low HDL-C: <40 mg/dl in men and <50 mg/dl in women, high blood pressure (BP): >130/85 mmHg, and high fasting glucose: >110 mg/dl. | 3 months | 
| Prevalence of lipodystrophy syndrome as defined by changes in fat by DXA | Comparison of changes in visceral and subcutaneous fat during current antiretroviral therapy for patients receiving current antiretroviral regimens and who never received thymidine analogues, didanosine, lopinavir, indinavir, or nelfinavir. | 6 meses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome | Correlations of visceral fat by DXA with fat accumulation, hypertension, diabetes or hypertriglyeceridemia | 3 months |