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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03635541
• Other study ID #: YYYY-2018-NAFLD
• Status: Recruiting
• Start date: August 23, 2018
• Est. completion date: December 2021

Study information

• Verified date: January 2019
• Source: Beijing Friendship Hospital
• Contact: Hong You, Doctor
• Phone: 861063139019
• Email: youhong30[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

No.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Fatty Liver
• Fibrosis
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fibrosis progrssion	dynamic changes in liver stiffness measured by VCTE/MRE	2 years
Primary	steatosis progression	dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF	2 years
Secondary	liver related events	liver decompensation (ascites, variceal bleeding, HE), HCC, liver transplantation, liver relted death.	2 years