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| ID | Type | Description | Link |
|---|---|---|---|
| EC 460/15 | Other Identifier | Ethics Committee |
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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.
Cross-sectional evaluation of two groups of patients:
The prevalence of Metabolic syndrome will be evaluated according to the different definitions (IDF, NCEP-ATP III, WHO).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of metabolic syndrome | Other | Evaluation and analytical determinations of the different components of the syndrome | ||
| Evaluation of changes in fat by DXA while on current therapy | Other | Comparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected patients on antiretroviral therapy with current drugs (excluding drugs previously associated with fat disturbance), and HIV-infected patients with previous evaluation of lipodystrophy syndrome in different severity, as determined by DXA and questionnaire.
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| Name | Affiliation | Role |
|---|---|---|
| Jose L Casado, MD | Ramon y Cajal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramon y Cajal Hospital | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D008060 | Lipodystrophy |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |