Screening for NAFLD-related Advanced Fibrosis in High Risk popuLation: Optimization of the Diabetology Pathway Referral Using Combinations of Non-invAsive Biological and elastogRaphy paramEters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Presence of individual F0 to F4 stage of fibrosis
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent causes of chronic liver disease worldwide. The current strategy proposed by the EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an over-referral in hepatology clinics. The proposed study will investigate the optimal strategy for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology clinics in order to reduce the over-referral to hepatology clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 40 and 80 years old,
- •Patients with diagnosis of T2DM* or obesity (defined according to World Health Organization as a BMI≥ 30 kg/m2)
- •Patient with hepatic steatosis determined by conventional abdominal ultrasound as defined by the EASL/EASO/EASD European guidelines.
- •Patient who agrees to be included in the study and who signs the informed consent form,
- •Patient affiliated to a healthcare insurance plan.
排除标准
- •Evidence of other causes of chronic liver disease:
- •History of ingestion of medications known to produce steatosis in the previous 6 months.
- •Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
- •Presence of regular and/or excessive use of alcohol (defined as >30g/day for males and >15g/day for females) for a period longer than 2 years at any times in the last 10 years
- •The subject is a pregnant or nursing female
- •Life expectancy less than 5 years
- •History of known HIV infection
- •History of type 1 diabete
- •BMI ≥ 40 kg/m2
- •Mentally unbalanced patients, under supervision or guardianship,
- •Patient deprived of liberty,
- •Patient who does not understand French/ is unable to give consent,
- •Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.
结局指标
主要结局
Presence of individual F0 to F4 stage of fibrosis
时间窗: 6 months
The presence of individual F0 to F4 stage of fibrosis as defined by histological stage in the liver biopsy using the NASH CRN Scoring System.
次要结局
- Fibroscan(6 months)