Clinical trial Recruiting at 1 site Observational Ages 18 to 70

NAFLD: Tracking Fibrosis and Steatosis Changes Over 10 Years in Biopsy-Proven Patients

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

Run by Beijing Friendship Hospital · NCT03635541 · Data updated 2026-11-12

This observational study follows adults with biopsy-proven nonalcoholic fatty liver disease for 10 years to see how fibrosis and fat buildup change over time.

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment500 (estimated)
SponsorBeijing Friendship Hospital
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedAugust 23, 2018
Main results expectedDecember 31, 2028
Study endsDecember 31, 2030
Registry record updatedSeptember 15, 2026
Trial IDNCT03635541 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–70 with biopsy-proven NAFLD who consent to long-term follow-up and regular testing.

Probably not a fit

Patients with other liver diseases, prior liver cancer, decompensated cirrhosis, major comorbidities limiting survival, or recent liver transplant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study enrolls adults aged 18 to 70 with biopsy-confirmed NAFLD and follows them for 10 years, with visits every six months. At each visit, researchers collect blood tests, including liver function, glucose and insulin, ferritin, and liver stiffness measurements, plus liver ultrasonography. The goal is to identify patterns in fibrosis and steatosis progression and related risk factors. The design is observational, with no experimental interventions beyond standard follow-up assessments. Location is Beijing, China, at Beijing Friendship Hospital, Capital Medical University.

Why it matters

Potential benefit: Findings could help identify predictors of fibrosis and steatosis progression in NAFLD, informing patient monitoring and risk stratification.

How similar studies have gone: Other observational NAFLD cohorts have provided insights into progression and risk factors, supporting the value of this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

  • Principal investigator: Hong You, Doctor — Beijing Friendship Hospital
  • Study coordinator: Hong You, Doctor
  • Email: youhong30@sina.com
  • Phone: 861063139019

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.