Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03635541

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Disease Attributes Disease Progression Fatty Liver Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Hong You, Doctor

PRINCIPAL_INVESTIGATOR

Yiwen Shi, Docor

CONTACT

[email protected]

8601063138665

About this study

No.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

observational group of NAFLD

Other

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

Primary outcomes

  1. fibrosis progrssion

    Time frame: 10 years

    dynamic changes in liver stiffness measured by VCTE/MRE

  2. steatosis progression

    Time frame: 10 years

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

Secondary outcomes

  1. liver related events

    Time frame: 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hong You, Doctor

CONTACT

[email protected]

861063139019

Jidong Jia, Doctor

CONTACT

[email protected]

861063139816

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2030
First posted
Aug 17, 2018
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.