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

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

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: Fibrotouch

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Lai Wei, MD; Phone Number: +86-010-56119511; Email: weelai@163.com
• Study Contact Backup: Name: Ming Yang, MD; Phone Number: +86-010-56119512; Email: ymicecream@163.com

Study Locations

• China
  • Bejing
    • Beijing, Bejing, China, 100034
      • Recruiting
      • Bejing Tsinghua Chang Gung Hospital
      • Contact: Ming Yang, MD; Phone Number: +86-010-56119512; Email: ymicecream@163.com
      • Contact: LAI WEI, MD; Phone Number: +86-010-56119511; Email: weilai@mail.tsinghua.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Group Assignment; Adults with health check-ups at multiple health examination centers across China	Diagnostic test: Fibrotouch; Fibrotouch will be performed showing the stiffness and fat content of liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	MAFLD means metabolic dysfunction-associated fatty liver disease; BMI means body mass index	through study completion, an average of 1 year
To assess the prevalence of type 2 diabetes among patients with MAFLD.	MAFLD means metabolic dysfunction-associated fatty liver disease	through study completion, an average of 1 year
To assess the prevalence of liver fibrosis and cirrhosis among patients with MAFLD.	MAFLD means metabolic dysfunction-associated fatty liver disease	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 10, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (ACTUAL): June 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: MAFLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CG-MAFLD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No