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Status unknownNCT05421572MAFLDUpdated Jun 16, 2022

Epidemiological Survey on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)

An observational study in Fatty Liver Disease, sponsored by Beijing Tsinghua Chang Gung Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
2,000
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

Read the detailed description

Non-Alcoholic Fatty Liver Disease (NAFLD) is the most common chronic liver disease all over the world (1). In early 2020, a new definition of MAFLD has been proposed and is becoming increasingly widely accepted. The new diagnostic criteria are based on the histology or imaging of liver biopsies, or even blood biomarker tests indicative of the presence of fatty liver while satisfying any one of the following three conditions: overweight/obesity, type 2 diabetes, or metabolic dysfunction (2). The information on the prevalence of MAFLD is scarce. This study is designed to conduct MAFLD screening in adults with health check-ups at multiple health examination centers across China. The primary objective is to investigate the prevalence of MAFLD among adults in China.

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Conditions studied

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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 96 studies on the registry; 52 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women and those who are implanted with pacemakers, stents or any other metal devices.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Single Group Assignment

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

    Diagnostic Test: Fibrotouch

Interventions

  • Diagnostic testFibrotouch

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

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What researchers measure

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

    Time frame: through study completion, an average of 1 year

Secondary outcomes

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

    MAFLD means metabolic dysfunction-associated fatty liver disease; BMI means body mass index

    Time frame: through study completion, an average of 1 year

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

    MAFLD means metabolic dysfunction-associated fatty liver disease; BMI means body mass index

    Time frame: through study completion, an average of 1 year

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

    MAFLD means metabolic dysfunction-associated fatty liver disease

    Time frame: through study completion, an average of 1 year

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

    MAFLD means metabolic dysfunction-associated fatty liver disease

    Time frame: through study completion, an average of 1 year

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 26707365 ↗
  • 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. PubMed 32278004 ↗

Individual participant data

Plan to share: Undecided — Not yet determined

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05421572
Lead sponsor
Beijing Tsinghua Chang Gung Hospital
Responsible party
Sponsor
First posted
Jun 16, 2022
Start date
Jun 10, 2022 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jun 16, 2022

Study contacts

Lai Wei, MD
Contact
weelai@163.com
+86-010-56119511
Ming Yang, MD
Contact
ymicecream@163.com
+86-010-56119512

Oversight

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

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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