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

Metabolic Associated Fatty Liver Disease-simplified Definition as an Optimized Risk Stratification Tool for Predicting Metabolic Outcomes in Real World

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Associated Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases

Detailed Description

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver diseases. It affects nearly 25% of the global population. 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. It may provide a better understanding of MAFLD, and optimize strategies for prevention of extrahepatic complications in clinical practice.

• Study Type: Observational
• Enrollment (Actual): 3372

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• diagnosed ad fatty liver by ultrasound

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of hypertension	We performed the cohort analysis for the outcome of hypertension. Hypertension was defined as the presence of any of the following conditions based on Revised Chinese Guidelines for Prevention and Treatment of Hypertension in 2018: a clinic systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg without the use of anti-hypertensive medications, or self-reported clinician-diagnosed hypertension.	7 years in a cohort study
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of carotid atherosclerotic plaque.	We performed the cohort analysis for the outcome of carotid atherosclerotic plaque. Carotid atherosclerotic plaque was assessed by recording ultrasonographic images of the right carotid artery according to Mannheim Intima-Media Thickness Consensus.	7 years in a cohort study

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital
• Investigators: Principal Investigator: Chengfu Xu, Dr, First affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: MAFLDS-1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No