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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04761900
Enrollment
3372
Registered
2021-02-21
Start date
2012-01-01
Completion date
2020-12-31
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Associated Fatty Liver Disease

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.

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.

Interventions

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

Sponsors

Ningbo No. 1 Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

Inclusion criteria

* diagnosed ad fatty liver by ultrasound

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of T2DM, hypertension, and carotid atherosclerotic plaque.7 years in a cohort studyWe 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.

Secondary

MeasureTime frameDescription
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of hypertension7 years in a cohort studyWe 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.
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of carotid atherosclerotic plaque.7 years in a cohort studyWe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026