Fatty Liver, Fatty Liver, Alcoholic, Non-alcoholic Fatty Liver Disease
Conditions
Brief summary
A multi-center, prospective cohort study on the natural history of fatty liver disease in China
Detailed description
This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with liver biopsy-proven macrovesicular steatosis (\>5%) will be enrolled in the baseline cross-sectional analysis. Those who are either diagnosed as NAFLD or ALD, if meeting all the inclusion and exclusion criteria, will be enrolled in the following cohort study, will be followed up after 1 year, 3 years and 5 years with a visit window of +1 month.
Interventions
None listed
Sponsors
Unimed Scientific Inc.
Fatty Liver and Alcoholic Liver Disease Study Group, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinically diagnosed fatty liver disease, confirmed by liver biopsy. * Specific biopsy requirements: qualified biopsy specimen within 6 months, \>5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope. * Only patients with NAFLD or ALD are eligible for the 5-year follow-up cohort study. * Willing to participate in the long-term follow-up and cooperative. * Able to provide informed consent file.
Exclusion criteria
* Unable to provide informed consent. * Patients are eligible for baseline cross-sectional analysis but not eligible for the cohort section, if having any of the following condition: 1. Any end-stage liver disease. 2. Any malignant tumor. 3. Any infection of hepatitis virus or HIV. 4. Any congenital liver disease such as Wilson disease. 5. Any other serious disease of projected survival \< 5 years. 6. Combined NAFLD and ALD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver cirrhosis | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| liver cancer | 5 years |
| liver failure | 5 years |
| type 2 diabetes | 5 years |
| cardiovascular and cerebrovascular events | 5 years |
| death | 5 years |
Countries
China
Contacts
Primary ContactJiangao Fan, MD
Backup ContactChao Sun, MD
Outcome results
None listed