Clinical trial NCT06864845: Risk of MASLD in Adults in Romania
Official title: Evaluation of Risk Factors for MASLD and Probability of Advanced Liver Disease in a the Romanian Arm of the the European Health Examination Survey (EHES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Factors
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Keywords: MASH, MASLD, risk, prevalence awareness
Lead sponsor: Internist.Ro
Sponsor class: OTHER
Collaborators: name: Transilvania University of Brasov
First posted: 2025-03-07
Enrollment: 5340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The EHES study aimed to enroll a representative sample of the adult population aged 25-64. Considering the structure of the Romanian population in this age group, a minimum sample size of 4235 enrollees was considered. Also, knowing from other European EHES studies that the enrollment rate was 50%, the pre study sample population selected from the lists of family doctors was 9600. Out of the total 9600, after excluding non-eligibles (893), refusals (2846) and incomplete evaluations (481), 5380 participants were included in the study.

Brief summary: 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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Definition of an at-risk for MASLD population in Romania based on metabolic and hepatic risk factors.
timeFrame: Baseline
Secondary outcomes:
measure: Identification of Patients with Known Liver Disease
timeFrame: Baseline
measure: Identification of a Population with Probable Advanced Liver Disease:
timeFrame: Baseline
measure: Identification of Potential Factors Associated with advanced liver disease.
timeFrame: Baseline
Other outcomes:
Locations:
city: Brasov
country: Romania
facility: Transylvania University School of Medicine
city: Bucharest
country: Romania
facility: National Institute for Public Health
Study officials:
References:
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