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

NCT ID: NCT04761900

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2020-12-31

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.

Conditions

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Metabolic Associated Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

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

Intervention Type DIAGNOSTIC_TEST

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.

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

Intervention Type DIAGNOSTIC_TEST

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.

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

Intervention Type DIAGNOSTIC_TEST

Interventions

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

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chengfu Xu, Dr

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Other Identifiers

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MAFLDS-1.0

Identifier Type: -

Identifier Source: org_study_id

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