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

NCT03635541 | Unknown DMC

• 1 other identifier: YYYY-2018-NAFLD
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• fibrosis progrssion

  dynamic changes in liver stiffness measured by VCTE/MRE

  2 years

• steatosis progression

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

  2 years

Secondary Outcomes (1)

• liver related events

  2 years

Study Arms (1)

observational group of NAFLD

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

Other: observational group of NAFLD

Interventions

observational group of NAFLD OTHER

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

observational group of NAFLD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non alcoholic fatty liver disease patients diagnosed with liver biopsy.

You may qualify if:

• \. 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.

You may not qualify if:

• \. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease.
• \. 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:
• 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,
• Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Fibrosis; Disease Progression

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Hong You, Doctor

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong You, Doctor

CONTACT

861063139019; youhong30@sina.com

Jidong Jia, Doctor

CONTACT

861063139816; jiamd@263.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Director of Liver Research Center

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: August 23, 2018
• Primary Completion: February 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

CN (1)