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

NCT ID: NCT03635541

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-23

Study Completion Date

2021-12-31

Brief Summary

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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

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No.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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observational group of NAFLD

Liver biopsy proved NAFLD patients, observational study. Oral advice on lifestyle would be given at each visit.

observational group of NAFLD

Intervention Type OTHER

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

Interventions

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observational group of NAFLD

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hong You

Vice-Director of Liver Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong You, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong You, Doctor

Role: CONTACT

861063139019

Jidong Jia, Doctor

Role: CONTACT

861063139816

Facility Contacts

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Yiwen Shi, Docor

Role: primary

8601063138665

Other Identifiers

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YYYY-2018-NAFLD

Identifier Type: -

Identifier Source: org_study_id

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