Fatty Liver Disease Collaborative Research in China

• Conditions: Fatty Liver; Fatty Liver, Alcoholic; Non-alcoholic Fatty Liver Disease

• Registration Number: NCT02391168
• Lead Sponsor: Fatty Liver and Alcoholic Liver Disease Study Group, China

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.

Study Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Study Start: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-05
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
liver cirrhosis	5 years

Secondary Outcome Measures

Name	Time	Method
liver cancer	5 years
type 2 diabetes	5 years
liver failure	5 years
death	5 years
cardiovascular and cerebrovascular events	5 years

Trial Locations

Locations (6)

Shanghai Xinhua Hospital; 🇨🇳 Shanghai, China

Zhangzhou Zhengxing Hospital; 🇨🇳 Zhangzhou, Fujian, China

Shandong Provincial Hospital; 🇨🇳 Ji'nan, Shandong, China

The Affiliated Hospital of Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China

Tianjin Second People's Hospital; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China