Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- fibrosis progrssion
研究概览
简要总结
It is an observational study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 500. Liver biopsy proved NAFLD patients will be recruited in this study for 10 years follow-up. Patients will be assessed at baseline, at every six months for blood count, liver function test, fasting blood-glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •1. 18-70 years of age,
- •liver biopsy proven non alcoholic fatty liver disease.
- •Agree to be followed up regularly;
- •Signature of written informed consent.
排除标准
- •1. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease.
- •2. Patients undergone bariatric surgery.
- •HIV infected patients.
- •Pregnant women.
- •Patients with severe diseases with expected survival less than 2 years.
- •Patients had followings before liver biopsy:
- •Hepatocellular carcinoma or suspected liver cancer,
- •Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
- •Other malignancy,
- •Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.
研究组 & 干预措施
observational group of NAFLD
Liver biopsy proved NAFLD patients, observational study. Oral advice on lifestyle would be given at each visit.
干预措施: observational group of NAFLD (Other)
结局指标
主要结局
fibrosis progrssion
时间窗: 2 years
dynamic changes in liver stiffness measured by VCTE/MRE
steatosis progression
时间窗: 2 years
dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF
fibrosis progrssion
时间窗: 10 years
dynamic changes in liver stiffness measured by VCTE/MRE
steatosis progression
时间窗: 10 years
dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF
次要结局
- liver related events(2 years)
- liver related events(10 years)
研究者
Hong You
Vice-Director of Liver Research Center
Beijing Friendship Hospital