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Clinical Trials in China / NCT03635541
Recruiting Observational

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

NCT03635541 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Friendship Hospital
Phase
Observational
Started
2018-08-23
Last updated
2026-09-15

Condition(s) studied

Non-Alcoholic Fatty Liver Disease

Investigational drug(s) / intervention(s)

observational group of NAFLD

observational group of NAFLD: there's no intervention for patients for it is a observational study

Study summary

It is an observational study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 500. Liver biopsy proved NAFLD patients will be recruited in this study for 10 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • fibrosis progrssion — 10 years
    dynamic changes in liver stiffness measured by VCTE/MRE
  • steatosis progression — 10 years
    dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF

Trial sites (1)

FacilityCityRegionStatus
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality Recruiting

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Feasibility Study of Deep Learning-based MDixon Quant for Quantitative Assessment of Chemotherapy-induced Fatty Liver Recruiting
BeijngFH Health Cohort Study Recruiting
Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With CHB and NAFLD Recruiting
Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal Recruiting
A Randomized, Double-blind, Single-center Phase I/IIa Study of XTYW007 Tablets in Subjects. Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03635541 on ClinicalTrials.gov ↗ ← All trials in China