NCT05546086

Brief Summary

Metabolic associated fatty liver disease(MEFLD) is a major chronic liver disease that can lead to various adverse events, such as liver cancer, cardiovascular disease, and chronic kidney disease. The present community-based cohort study enrolls subjects who take health physical examinations at the sub-center outpatient department, Beijing Friendship Hospital. Investigators collect their baseline information, including demographic data, clinical history, physical examination, laboratory results, imageological examination, and so on. Follow-up surveys are conducted annually and the information collected is the same as the baseline. The outcome information, including cardiovascular disease, malignancy, liver cirrhosis, liver decompensation, liver transplantation, and all-cause mortality, are obtained by linking to the hospital discharge database and death registration system of Beijing. The primary aim of the study is to build a risk-stratified evaluation system for MAFLD through the cohort.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,103

participants targeted

Target at P75+ for all trials

Timeline
70mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Apr 2022Apr 2032

Study Start

First participant enrolled

April 18, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2032

Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

10 years

First QC Date

September 15, 2022

Last Update Submit

September 18, 2022

Conditions

Keywords

Non-Alcoholic Fatty Liver DiseaseCohort StudiesRisk Factors

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular disease

    Incidence of cardiovascular disease during follow-ups

    1 to 10 years

Secondary Outcomes (5)

  • Malignancy

    1 to 10 years

  • Liver cirrhosis

    1 to 10 years

  • Liver decompensation

    1 to 10 years

  • Liver transplantation

    1 to 10 years

  • All-cause mortality

    1 to 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The present community-based cohort study enrolls subjects who take health physical examinations at the sub-center outpatient department, Beijing Friendship Hospital from April 2022.

You may qualify if:

  • Aged 18 years or older
  • Permanent residents in Beijing
  • Signing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Hong You, Doctor

CONTACT

Xinyu Zhao, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 19, 2022

Study Start

April 18, 2022

Primary Completion (Estimated)

April 18, 2032

Study Completion (Estimated)

April 18, 2032

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations