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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03635541

Enrollment

500

Registered

2018-08-17

Start date

2018-08-23

Completion date

2030-12-31

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

non alcoholic fatty liver disease, non alcoholic steatohepatitis, steatosis, fibrosis, progression, risk factors

Brief 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.

Detailed description

No.

Interventions

OTHERobservational group of NAFLD

there's no intervention for patients for it is a observational study

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
liver related events	10 years	liver decompensation (ascites, variceal bleeding, HE), HCC, liver transplantation, liver relted death.

Countries

China

Contacts

CONTACTHong You, Doctor

youhong30@sina.com861063139019

CONTACTJidong Jia, Doctor

jiamd@263.net861063139816

PRINCIPAL_INVESTIGATORHong You, Doctor

Beijing Friendship Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026