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

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Other: observational group of NAFLD

• Registration Number: NCT03635541
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

It is an observational study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 90. Liver biopsy proved NAFLD patients will be recruited in this study for 2 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.

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-17
• Study Start: 2018-08-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25
• Primary Completion: 2021-02
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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:

  3. Hepatocellular carcinoma or suspected liver cancer,

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

  5. Other malignancy,

  6. Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational group of NAFLD	observational group of NAFLD	Liver biopsy proved NAFLD patients, observational study. Oral advice on lifestyle would be given at each visit.

Primary Outcome Measures

Name	Time	Method
fibrosis progrssion	2 years	dynamic changes in liver stiffness measured by VCTE/MRE
steatosis progression	2 years	dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF

Secondary Outcome Measures

Name	Time	Method
liver related events	2 years	liver decompensation (ascites, variceal bleeding, HE), HCC, liver transplantation, liver relted death.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China