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RecruitingNCT03635541Updated Sep 15, 2026

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

An observational study in Non-Alcoholic Fatty Liver Disease, sponsored by Beijing Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Beijing Friendship Hospital · Observational

From the registry’s dates

  • Started Aug 2018; still recruiting 8 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

No.

02

Conditions studied

  • Non-Alcoholic Fatty Liver Disease

Keywords

  • non alcoholic fatty liver disease
  • non alcoholic steatohepatitis
  • steatosis
  • fibrosis
  • progression
  • risk factors
03

In context

Non-alcoholic Fatty Liver Disease

1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.

This study's planned enrollment of 500 is above the median of 153 across 390 observational studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 217 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Non alcoholic fatty liver disease patients diagnosed with liver biopsy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. 18-70 years of age, 2. liver proven non alcoholic fatty liver disease. 3. Agree to be followed up regularly; 4. Signature of written .

Exclusion criteria

Exclusion Criteria:

  • 1. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, liver diseases, drug induced liver diseases, genetic metabolic liver disease.

    2. Patients undergone bariatric surgery. 3. infected patients. 4. Pregnant women. 5. Patients with severe diseases with expected survival less than 2 years. 6. Patients had followings before liver :

    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 ,
    4. Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Otherobservational group of NAFLD

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

06

What researchers measure

Primary outcomes

  1. fibrosis progrssion

    dynamic changes in liver stiffness measured by VCTE/MRE

    Time frame: 10 years

  2. steatosis progression

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

    Time frame: 10 years

Secondary outcomes

  1. liver related events

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

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing Municipality 100050, China
    Recruiting
    • Yiwen Shi, Docor · Contactyiwenshi90@163.com · 8601063138665
    • Hong You, Doctor · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03635541
Responsible party
Hong You (Vice-Director of Liver Research Center, Beijing Friendship Hospital) — Principal investigator
First posted
Aug 17, 2018
Start date
Aug 23, 2018
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 15, 2026

Study contacts

Hong You, Doctor
Contact
youhong30@sina.com
861063139019
Jidong Jia, Doctor
Contact
jiamd@263.net
861063139816
Hong You, Doctor
principal investigator · Beijing Friendship Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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