About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. 18-70 years of age, 2. liver biopsy proven non alcoholic fatty liver disease. 3. Agree to be followed up regularly; 4. Signature of written informed consent.
Disqualifiers
1. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease.
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,
Trial population
Non alcoholic fatty liver disease patients diagnosed with liver biopsy.
Trial design
Cohort
Other
Treatments tested in this trial
observational group of NAFLD
Other interventionthere's no intervention for patients for it is a observational study
Treatment groups
Trial outcomes
Primary outcomes
fibrosis progrssion
dynamic changes in liver stiffness measured by VCTE/MRE
steatosis progression
dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF
Secondary outcomes
liver related events
liver decompensation (ascites, variceal bleeding, HE), HCC, liver transplantation, liver relted death.
Sponsors and contacts
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