Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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It is an observational study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 90. Liver biopsy proved NAFLD patients will be recruited in this study for 2 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.

Detailed Description
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No.

Official Title
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Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: observational group of NAFLD


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational group of NAFLD<br>Liver biopsy proved NAFLD patients, observational study. Oral advice on lifestyle would be given at each visit. | Other: observational group of NAFLD<br>* there's no intervention for patients for it is a observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibrosis progrssion | dynamic changes in liver stiffness measured by VCTE/MRE | 2 years | 
| steatosis progression | dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver related events | liver decompensation (ascites, variceal bleeding, HE), HCC, liver transplantation, liver relted death. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non alcoholic fatty liver disease, non alcoholic steatohepatitis, steatosis, fibrosis, progression, risk factors