A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database
- Registration Number
- NCT06741111
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1200000
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])
- 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 1. 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of people with low/intermediate/high risk of advanced fibrosis in EASL at risk population based on EASL 2024 care pathway. January 1st, 2023, to December 31st, 2023 Number and proportion of people in respective risk population
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇳Bangalore, India