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

Metabolic Associated Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761900
• Other study ID #: MAFLDS-1.0
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3372
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• diagnosed ad fatty liver by ultrasound

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Associated Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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