Non-Alcoholic Fatty Liver DiseaseNCT03635541
Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease, run by Beijing Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- observational group of NAFLD
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2018to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non alcoholic fatty liver disease patients diagnosed with liver biopsy.
Who may be able to join
- 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.
Who cannot join
- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Yiwen Shi, Docor, 8601063138665, yiwenshi90@163.com
Hong You, Doctor
About this study
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- observational group of NAFLD
- Keywords
- non alcoholic fatty liver disease, non alcoholic steatohepatitis, steatosis, fibrosis, progression, risk factors
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Fibrosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational group of NAFLDOther
there's no intervention for patients for it is a observational study
| Study group | Role | What they receive |
|---|---|---|
| observational group of NAFLD | Liver biopsy proved NAFLD patients, observational study. Oral advice on lifestyle would be given at each visit. Receives: Other: observational group of NAFLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrosis progrssion
dynamic changes in liver stiffness measured by VCTE/MRE
Measured: 10 years
steatosis progression
dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF
Measured: 10 years
Secondary outcomes (1)
liver related events
liver decompensation (ascites, variceal bleeding, HE), HCC, liver transplantation, liver relted death.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start23 Aug 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
- Investigators
- Hong You, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635541
- Sponsor's protocol ID
- YYYY-2018-NAFLD
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2018
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03635541
- Acronym / sponsor ID
- YYYY-2018-NAFLD
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- non alcoholic fatty liver disease, non alcoholic steatohepatitis, steatosis, fibrosis, progression, risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
No.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group of NAFLD | – | Other: observational group of NAFLDLiver biopsy proved NAFLD patients, observational study. Oral advice on lifestyle would be given at each visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non alcoholic fatty liver disease patients diagnosed with liver biopsy.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational group of NAFLDthere's no intervention for patients for it is a observational study | Other | observational group of NAFLD |
Primary outcome
fibrosis progrssion
Time frame: 10 years
dynamic changes in liver stiffness measured by VCTE/MRE
steatosis progression
Time frame: 10 years
dynamic changes in liver fat measured by controlled attenuation parameter/MRI-PDFF
1 secondary outcome
liver related events
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong You, Doctor principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong You, Doctor (861063139019, youhong30@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fibrosis progrssion (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.