Lipodystrophy, Metabolic Syndrome
Conditions
Brief summary
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
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).
Interventions
OTHEREvaluation of metabolic syndrome
Evaluation and analytical determinations of the different components of the syndrome
OTHEREvaluation 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
Sponsors
Asociacion para el Estudio de las Enfermedades Infecciosas
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III) | 3 months | 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. |
| Prevalence of lipodystrophy syndrome as defined by changes in fat by DXA | 6 meses | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome | 3 months | Correlations of visceral fat by DXA with fat accumulation, hypertension, diabetes or hypertriglyeceridemia |
Countries
Spain
Outcome results
None listed