Risk of MASLD in Adults in Romania (MASLD Ro)

Internist.Ro

Status: Completed

Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Risk Factors

Study type: Observational

Funder types: Other

Identifiers

NCT06864845

PDP1/NT2311/13.05.2020 (Other Identifier)

A002

Details and patient eligibility

About

This study aims to evaluate the presence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) risk factors and estimate the probability of advanced liver disease in a Romanian cohort from the European Health Examination Survey (EHES). Using standardized clinical, anthropometric, and laboratory data, the study will assess metabolic and alcohol-related contributors to liver disease. The primary focus is to identify an at-risk MASLD population, characterize associated metabolic risk factors, and evaluate disease awareness through the presence of ICD-10 diagnostic codes for liver disease.

The study applies the Forns Score as a validated non-invasive tool for assessing liver fibrosis risk and incorporates the latest EASL-AASLD 2024 guidelines to define MASLD, MASH, Alcohol-Related Liver Disease (ALD), and MetALD (combined metabolic and alcohol-related liver disease). Additionally, it will explore potential underdiagnosis rates of liver disease by comparing clinical risk markers with documented diagnoses.

The study is a post hoc, cross-sectional, retrospective analysis and does not involve new data collection or patient contact. Data analysis will be performed using descriptive statistics, subgroup comparisons, and multivariate models to assess relationships between metabolic risk factors, MASLD probability, and liver disease awareness. This research will contribute to the understanding of MASLD epidemiology in Romania and inform public health strategies for early detection and prevention.

Full description

Detailed Description

This study is designed as a post hoc analysis of data from the European Health Examination Survey (EHES) - Romania, focusing on MASLD risk factors and advanced liver disease probability. The EHES is a large-scale population survey conducted in European countries, with standardized methodologies for data collection, ensuring comparability across different nations.

Study Objectives Primary Objective: Define an at-risk MASLD population in Romania.

Secondary Objectives:

Identify additional liver disease risk factors (viral hepatitis, iron overload, alcohol consumption).

Identify a population of confirmed advanced liver disease patients. Assess hepatitis prevalence vs. disease awareness (ICD-10 coding). Identify potential risk factors associated with hepatitis.

Study Design and Methodology Study Type: Observational, cross-sectional, retrospective. Data Source: EHES Romania dataset. Population: Adults (≥18 years) included in the EHES survey. Exclusion Criteria: Missing Forns Score variables (platelet count, total cholesterol, gamma-glutamyl transferase, age).

Sample Size Estimation: Based on MASLD prevalence (25-30%), minimum n=1000-1500 for subgroup analyses. (5300 available) Definition of Liver Disease Subtypes (EASL-AASLD 2024 Guidelines) MASLD: Hepatic steatosis with at least one metabolic risk factor. MASH: Progressive MASLD with hepatocellular injury and fibrosis. ALD: Liver disease in individuals exceeding alcohol thresholds (≥30g/day men, ≥20g/day women).

MetALD: Overlap of MASLD and ALD.

Statistical Analysis Plan Descriptive statistics for population characteristics and MASLD prevalence. Subgroup comparisons (MASLD vs. non-MASLD, ALD vs. non-ALD, etc.). Multivariate logistic regression for risk factor associations. Sensitivity analysis for missing data handling. Quality Assurance and Data Management EHES follows standardized data validation, quality control, and external audits.

Data checks and verification against medical records ensure accuracy. No new data collection or patient interaction in this study.

Ethical Considerations The EHES obtained informed consent from all participants [PMID: 39491016]. This study uses anonymized, pre-existing data. No ethical approval needed beyond EHES compliance. Data Sharing Statement Individual participant data will not be publicly available. Aggregated results will be shared upon request. Funding Statement No external funding. Study Timeline Data analysis starts: 20/02/2025 Expected completion:1/04/2025

Enrollment: 5,340 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Participation in the EHES Romania study

Exclusion criteria

Missing essential data preventing reliable MASLD and liver disease risk assessment:

• Missing biochemical data (ALT, GGT, platelets, cholesterol)
• Missing clinical and anthropometric data (age, weight and height)

Trial design

5,340 participants in 5 patient groups

MASLD-At-Risk Cohort

Description:

Individuals meeting MASLD criteria based on metabolic dysfunction risk factors and hepatic steatosis.

MASH Cohort

Description:

Subgroup with MASLD who meet additional criteria for hepatic inflammation and fibrosis risk.

Alcohol-Related Liver Disease (ALD) Cohort:

Description:

Participants exceeding alcohol consumption thresholds who exhibit liver dysfunction and no other risk factors for liver diseas

MetALD Cohort:

Description:

Individuals exhibiting both MASLD and ALD characteristics, requiring combined metabolic and alcohol-related assessment and no other risk factors for liver disease

Non-MASLD Control Group

Description:

Participants with no significant metabolic dysfunction and normal liver function and no other risk factors for liver disease serving as a reference population.