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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBeijing Friendship Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease.

Hepatocellular carcinoma or suspected liver cancer,

Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;

Other malignancy,

Trial population

Non alcoholic fatty liver disease patients diagnosed with liver biopsy.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • observational group of NAFLD

    Other intervention

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: observational group of NAFLD1 intervention

Trial outcomes

Primary outcomes

1

fibrosis progrssion

dynamic changes in liver stiffness measured by VCTE/MRE

Time frame
10 years
2

steatosis progression

dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF

Time frame
10 years

Secondary outcomes

1

liver related events

liver decompensation (ascites, variceal bleeding, HE), HCC, liver transplantation, liver relted death.

Time frame
10 years

Other outcomes

Sponsors and contacts

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