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

• Conditions: Fatty Liver Disease
• Interventions: Diagnostic Test: Fibrotouch

• Registration Number: NCT05421572
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-06-06
• Study Start: 2022-06-10
• Study First Submitted QC: 2022-06-13
• Last Update Submitted: 2022-06-13
• Study First Posted: 2022-06-16
• Last Update Posted: 2022-06-16
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Group Assignment	Fibrotouch	Adults with health check-ups at multiple health examination centers across China

Primary Outcome Measures

Name	Time	Method
To investigate the prevalence of MAFLD among adults at multiple health examination centers across China.	through study completion, an average of 1 year	MAFLD means metabolic dysfunction-associated fatty liver disease

Secondary Outcome Measures

Name	Time	Method
To assess the prevalence of type 2 diabetes among patients with MAFLD.	through study completion, an average of 1 year	MAFLD means metabolic dysfunction-associated fatty liver disease
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	MAFLD means metabolic dysfunction-associated fatty liver disease; BMI means body mass index
To assess the proportion of overweight or obese patients with MAFLD (BMI≥23 kg/m²).	through study completion, an average of 1 year	MAFLD means metabolic dysfunction-associated fatty liver disease; BMI means body mass index
To assess the prevalence of liver fibrosis and cirrhosis among patients with MAFLD.	through study completion, an average of 1 year	MAFLD means metabolic dysfunction-associated fatty liver disease

Trial Locations

Locations (1)

Bejing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, Bejing, China