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

Sponsor
Beijing Tsinghua Chang Gung Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05421572
Collaborator
(none)
2,000
1
6.7
298.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Epidemiological Survey on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
Anticipated Study Start Date :
Jun 10, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bejing Tsinghua Chang Gung Hospital Beijing Bejing China 100034

Sponsors and Collaborators

  • Beijing Tsinghua Chang Gung Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier:
NCT05421572
Other Study ID Numbers:
  • CG-MAFLD-001
First Posted:
Jun 16, 2022
Last Update Posted:
Jun 16, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beijing Tsinghua Chang Gung Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2022