NCT04215926Unknown不适用
The Epidemiological Investigation and Pathogenesis of NAFLD in HIV-infected Patients: a Cross-sectional Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- morbidity of nonalcoholic fatty liver disease
研究概览
简要总结
The prevalence of NAFLD (nonalcoholic fatty liver disease) in HIV-infected patients is higher than that in general population, but the causes of morbidity and pathogenesis have not been fully explored. The investigators are planning to consecutively enroll 400 cases HIV-positive outpatients, and to detect NAFLD by ultrasound. The fecal and blood samples were also collected to explore the mechanism of NAFLD. The investigators aimed to determine the prevalence and risk factors of NAFLD in HIV infected patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~70 y;
- •HIV-positive patients;
- •written the informed consent
排除标准
- •coinfected with HBV, HCV;
- •secondary causes of fatty liver (eg, consumption of amiodarone and tamoxifen) and decompensated liver disease;
- •significant alcohol consumption (>20 g per day for man, >10 g per day for woman);
- •received antibiotics in preceding two months;
- •autoimmune disease;
- •severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
- •pregnant or lactating women
结局指标
主要结局
morbidity of nonalcoholic fatty liver disease
时间窗: 1 month
NAFLD was diagnosed using ultrasound
次要结局
未报告次要终点
研究者
Hongzhou Lu
professor
Shanghai Public Health Clinical Center
研究点 (1)
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