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NCT03635541
Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease
Conditions: Non-Alcoholic Fatty Liver Disease
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Enrollment: 500
Sponsor: Beijing Friendship Hospital
Location: Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality
Summary
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
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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. 3. HIV infected patients. 4. Pregnant women. 5. Patients with severe diseases with expected survival less than 2 years. 6. Patients had followings before liver biopsy:
1. Hepatocellular carcinoma or suspected liver cancer,
2. Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
3. Other malignancy,
4. Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.
Source: ClinicalTrials.gov (NCT03635541). StuddyBuddy aggregates publicly available trial information.