NCT04282447Unknown不适用
Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年8月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics
研究概览
简要总结
The aim of the present study is to assess, by using a simple algorithm combining FIB-4 and Fibroscan, the prevalence of NASH with advanced fibrosis in outpatients followed in various hospital specialty clinics other than hepato/gastroenterology and to examine risk factors associated with this condition. The prevalence of NASH will be investigated among 6 cohorts of outpatients followed in different hospital specialty clinics at Hôpitaux Universitaires de Strasbourg.
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
- 否
入选标准
- •age ≥ 18 years
- •outpatients followed at specialty clinics in HUS and at risk of NAFLD: with at least one metabolic risk factor (overweight, diabetes mellitus, hypertension, hypertriglyceridemia) and/or elevated transaminases and/or liver steatosis on US.
- •endocrinology cohort : type 2 diabetes patients
- •infectious disease cohort : HIV positive patients
- •rheumatology cohort : patients with psoriasis, gout or rheumatoid arthritis
- •nephrology cohort : patients with chronic kidney disease such as diabetic nephropathy or hypertensive nephropathy, including those receiving hemodialysis.
- •cardiology cohorts: patients with history of angina, myocardial infarction, stroke or arteritis of lower limbs.
- •internal medicine cohort: patients with auto immune systemic diseases such as lupus, sclerosis or rheumatoid arthritis.
- •subjects who have given their informed consent
- •Subjects affiliated to a social security system
排除标准
- •alcohol consumption > 30g/d in male or > 20g/d in female in the past 6 months
- •history of chronic viral hepatitis
- •history of liver auto immune disease, genetic hemochromatosis, Wilson disease
- •biliary disease, bile duct obstruction
- •drug-induced liver injury
- •secondary liver cancer or other active cancer
- •organ graft
- •use of medications associated with secondary NAFLD (corticosteroids, tamoxifen, amiodarone, methotrexate).
- •congestive heart failure
- •pregnancy, breastfeeding
- •no information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.)
- •patient under guardianship
- •patients under judicial protection
结局指标
主要结局
Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics
时间窗: 3 months
To assess the estimated prevalence of NASH , calcul of the FIB4
次要结局
未报告次要终点
研究者
研究点 (1)
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