NCT05421572

Brief Summary

To investigate the prevalence of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) among adults in China

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 6, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 16, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

June 6, 2022

Last Update Submit

June 13, 2022

Conditions

Keywords

MAFLD

Outcome Measures

Primary Outcomes (1)

  • To investigate the prevalence of MAFLD among adults at multiple health examination centers across China.

    MAFLD means metabolic dysfunction-associated fatty liver disease

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • To assess the proportion of overweight or obese patients with MAFLD (BMI≥23 kg/m²).

    through study completion, an average of 1 year

  • To assess the prevalence of metabolic dysfunction among patients with MAFLD who are lean or normal in body weight (BMI < 23 kg/m²)

    through study completion, an average of 1 year

  • To assess the prevalence of type 2 diabetes among patients with MAFLD.

    through study completion, an average of 1 year

  • To assess the prevalence of liver fibrosis and cirrhosis among patients with MAFLD.

    through study completion, an average of 1 year

Study Arms (1)

Single Group Assignment

Adults with health check-ups at multiple health examination centers across China

Diagnostic Test: Fibrotouch

Interventions

FibrotouchDIAGNOSTIC_TEST

Fibrotouch will be performed showing the stiffness and fat content of liver

Single Group Assignment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adults with health check-ups at multiple health examination centers across China.

You may qualify if:

  • Aged between 18 and 75, both sex;
  • Able to sign informed consent.

You may not qualify if:

  • Pregnant women and those who are implanted with pacemakers, stents or any other metal devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bejing Tsinghua Chang Gung Hospital

Beijing, Bejing, 100034, China

RECRUITING

Related Publications (2)

  • Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.

    PMID: 26707365BACKGROUND
  • Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.

    PMID: 32278004BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 16, 2022

Study Start

June 10, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 16, 2022

Record last verified: 2022-05

Locations