MAFLD-simplified Definition as an Optimized Risk Stratification Tool for Predicting Metabolic Outcomes

NCT04761900 | Completed DMC

• 1 other identifier: MAFLDS-1.0
• Study Type: observational
• Target: 3,372
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries.

Conditions

Metabolic Associated Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of T2DM, hypertension, and carotid atherosclerotic plaque.

  We performed the cohort analysis for the outcome of T2DM. T2DM was defined as the presence of any of the following conditions based on the American Diabetes Association criteria: FPG ≥126 mg/dL, HbA1c ≥6.5%; or self-reported clinician-diagnosed T2DM.

  7 years in a cohort study

Secondary Outcomes (2)

• Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of hypertension

  7 years in a cohort study

• Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of carotid atherosclerotic plaque.

  7 years in a cohort study

Study Arms (3)

participants were followed for the incidence of T2DM in a cohort study

performed a cohort analysis for T2DM. For incident T2DM cases, calculate the follow-up time from the date of enrollment into our study to the date of T2DM diagnosis.

Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases

participants were followed for the incidence of hypertension in a cohort study

performed a cohort analysis for hypertension. For incident hypertension cases, calculate the follow-up time from the date of enrollment into our study to the date of hypertension diagnosis.

Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases

participants were followed for the incidence of carotid atherosclerotic plaque in a cohort study

performed a cohort analysis for carotid atherosclerotic plaque. For incident carotid atherosclerotic plaque cases, calculate the follow-up time from the date of enrollment into our study to the date of carotid atherosclerotic plaque diagnosis.

Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases

Interventions

the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases DIAGNOSTIC_TEST

participants were followed for the incidence of T2DM in a cohort study; participants were followed for the incidence of carotid atherosclerotic plaque in a cohort study; participants were followed for the incidence of hypertension in a cohort study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese adults who took annual health check-ups were enrolled in this study during 2012.

You may qualify if:

• diagnosed ad fatty liver by ultrasound

You may not qualify if:

• Missing data on Ultrasound, blood glucose, BMI and metabolic status.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Officials

• Chengfu Xu, Dr

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2012
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02