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 type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 23, 2018 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT03635541 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.