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

Fatty Liver Disease Clinical Trial

— MAFLD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421572
• Other study ID #: CG-MAFLD-001
• Status: Recruiting
• Start date: June 10, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Lai Wei, MD
• Phone: +86-010-56119511
• Email: weelai[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver Disease
• Liver Diseases

Intervention

Diagnostic Test:
• Fibrotouch
Fibrotouch will be performed showing the stiffness and fat content of liver

Locations

Country	Name	City	State
China	Bejing Tsinghua Chang Gung Hospital	Beijing	Bejing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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-Järvinen H, Fan JG, Grønbæk 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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