CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,340 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT06864845
NCT06864845N/ACompleted

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)

Internist.Ro·observational·Posted Mar 7, 2025·Updated Mar 12, 2025

In Brief

An observational study for Risk Factors and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease. Completed, enrolled 5,340 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesRomania

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 7, 2025
Enrollment StartAug 1, 2022
Primary CompletionOct 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 1.3 years ago