Cross-sectional Study on the Prevalence of Fatty Liver and Metabolic Risk Factors in an HIV-infected Population
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Prevalence of significant hepatic fibrosis
研究概览
简要总结
Monocentric, cross-sectional study to define the prevalence of advanced fibrosis in an HIV infected outpatient population. Follow-up over 10 years to assess clinical relevance.
详细描述
Globally a shift in the spectrum of diseases has occurred. While in earlier year's infectious (communicable) disease were the main contributors to morbidity and mortality, today non-communicable diseases (NCD) exhibit a dramatic increase and have reached epidemic proportions, even in developing countries. Diabetes, cardiovascular disease, and cancer are the most frequent NCDs and the underlying risk factors including Insulin resistance, dyslipidemia and obesity have been increasing over the last decades. The current study explores the prevalence of advanced fibrosis in an HIV-infected outpatient study population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
排除标准
- •pregnancy
- •disease with expectation of life under 12 months
结局指标
主要结局
Prevalence of significant hepatic fibrosis
时间窗: 1 year
Significant hepatic fibrosis defined as greater or equal to \>8,2 kPa meassured by transient elastography using a Fibroscan
次要结局
- Prevalence of hepatic steatosis(1 year)
- Incidence of events of interest (clinical outcome)(10 years)
研究者
Jörn M. Schattenberg
Jörn Schattenberg, MD; Head of the Metabolic Liver Research Program
Johannes Gutenberg University Mainz