Prevalence of Lipodystrophy Syndrome and Secondary Metabolic Syndrome in HIV-infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection
- •Older than 18 years
- •Receiving first or second antiretroviral regimen or
- •Previous evaluation and classification of lipodystrophy syndrome
排除标准
- •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)
结局指标
主要结局
Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)
时间窗: 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
时间窗: 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.
次要结局
- Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome(3 months)