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临床试验/NCT06741111
NCT06741111已完成不适用

A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 1,233,970 人开始时间: 2025年1月21日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
1,233,970
试验地点
1
主要终点
The proportion of people with low/intermediate/high risk of advanced fibrosis in EASL at risk population based on EASL 2024 care pathway.

研究概览

简要总结

The primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk Chinese population based on the European Association for the Study of the Liver (EASL) 2024 care pathway

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For All and Study population:
  • Male or female, age above or equal to 18 years on health-check-up visit day
  • No missing value on sex
  • For EASL at risk population
  • Must be part of study population.
  • People with T2D or [obesity+above or equal to 1 cardiometabolic risk factor(s)] or elevated liver enzymes
  • For EASL not at-risk population
  • Must be part of study population.
  • For EASL-SAFE
  • Must be part of EASL at risk population
  • For AGA at risk population
  • Must be part of study population.
  • People with 2 or more metabolic risk factors (EASL-MASLD criteria) or T2D or steatosis on any imaging modality or with elevated aminotransferases
  • For CSH MAFLD population
  • Must be part of study population.
  • Liver steatosis on abdominal ultrasound
  • With at least one component of Metabolic syndrome (MetS [CSH])

排除标准

  • Individuals originating from centers with fewer than 100 participants
  • Missing value of liver stiffness measurement (LSM)
  • Had an interquartile range/median ratio above or equal to 30% of the measurement of LSM
  • Missing value on either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or platelet count (PLT)
  • Missing value on FPG, TG, HDLc or BP (to define the presence of metabolic risk factors)
  • Missing value on abdominal ultrasound
  • For EASL not at-risk population
  • People with T2D or [obesity+above or equal to 1 cardiometabolic risk factor(s)] or elevated liver enzymes
  • For EASL-SAFE/NFS
  • Missing value on globulin

结局指标

主要结局

The proportion of people with low/intermediate/high risk of advanced fibrosis in EASL at risk population based on EASL 2024 care pathway.

时间窗: January 1st, 2023, to December 31st, 2023

Number and proportion of people in respective risk population

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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