Clinical trial NCT06741111: A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database
Official title: A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 1233970
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who underwent health check-up in Meinian check-up centres between January 1st, 2023 to December 31st, 2023 and met the eligibility criteria.

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


Eligibility criteria: Inclusion Criteria:

For All and Study population:

1. Male or female, age above or equal to 18 years on health-check-up visit day
2. No missing value on sex

For EASL at risk population

1. Must be part of study population.
2. People with T2D or \[obesity＋above or equal to 1 cardiometabolic risk factor(s)\] or elevated liver enzymes

For EASL not at-risk population

1. Must be part of study population.

For EASL-SAFE

1. Must be part of EASL at risk population

For AGA at risk population

1. Must be part of study population.
2. 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

1. Must be part of study population.
2. Liver steatosis on abdominal ultrasound
3. With at least one component of Metabolic syndrome (MetS \[CSH\])

Exclusion Criteria:

1. Individuals originating from centers with fewer than 100 participants
2. Missing value of liver stiffness measurement (LSM)
3. Had an interquartile range/median ratio above or equal to 30% of the measurement of LSM
4. Missing value on either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or platelet count (PLT)
5. Missing value on FPG, TG, HDLc or BP (to define the presence of metabolic risk factors)
6. 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

1. Missing value on globulin

Primary outcomes:
measure: The proportion of people with low/intermediate/high risk of advanced fibrosis in EASL at risk population based on EASL 2024 care pathway.
timeFrame: January 1st, 2023, to December 31st, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: