Clinical trial NCT05421572: Epidemiological Survey on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
Official title: Epidemiological Survey on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fatty Liver Disease
Keywords: MAFLD
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adults with health check-ups at multiple health examination centers across China.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To investigate the prevalence of MAFLD among adults at multiple health examination centers across China.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: To assess the proportion of overweight or obese patients with MAFLD (BMI≥23 kg/m²).
timeFrame: through study completion, an average of 1 year
measure: To assess the prevalence of metabolic dysfunction among patients with MAFLD who are lean or normal in body weight (BMI < 23 kg/m²)
timeFrame: through study completion, an average of 1 year
measure: To assess the prevalence of type 2 diabetes among patients with MAFLD.
timeFrame: through study completion, an average of 1 year
measure: To assess the prevalence of liver fibrosis and cirrhosis among patients with MAFLD.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bejing Tsinghua Chang Gung Hospital
state: Bejing
Study officials:
References:
citation: 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.
citation: 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.