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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Metabolic Associated Fatty Liver Disease

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed ad fatty liver by ultrasound Exclusion Criteria: Missing data on Ultrasound, blood glucose, BMI and metabolic status.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| participants were followed for the incidence of T2DM in a cohort study<br>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<br> <br> |
| participants were followed for the incidence of hypertension in a cohort study<br>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<br> <br> |
| participants were followed for the incidence of carotid atherosclerotic plaque in a cohort study<br>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<br> <br> |

What is the study measuring?
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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 |