Risk of MASLD in Adults in Romania

Completed

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

• Registration Number: NCT06864845
• Lead Sponsor: Internist.Ro

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

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Study First Submitted: 2025-02-19
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5340

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Definition of an at-risk for MASLD population in Romania based on metabolic and hepatic risk factors.	Baseline	Classification for the composite outcome requires the presence of at least one of the following five cardiometabolic risk factors: Overweight or Obesity: Defined by a Body Mass Index (BMI) ≥25 kg/m² for non-Asians and ≥23 kg/m² for Asians.; Type 2 Diabetes Mellitus: A confirmed diagnosis of type 2 diabetes. Insulin Resistance: Indicators include fasting glucose levels ≥100 mg/dL or HbA1c ≥5.7%.; Dyslipidemia: Characterized by triglycerides ≥150 mg/dL or reduced HDL cholesterol levels (\<40 mg/dL for men and \<50 mg/dL for women).; Hypertension: Blood pressure readings ≥130/85 mmHg or the use of antihypertensive medications.; Unit of Measure: Percentage of total study population.

Secondary Outcome Measures

Name	Time	Method
Identification of Patients with Known Liver Disease	Baseline	Description: The proportion of individuals with known liver disease; Other known liver diseases will be accepted according to ICD-10: B18.0, B18.1, B18.8, B18.9, K75.4, E83.0, K74.3, K83.01, D86.8, D86.9, M35.00, M35.09 , K74.60, K74.69, K70.30, K70.31, K74.0, K74.1, K74.2, K76.0, K75.81; Unit of Measure: Percentage of participants with known liver disease from the sample
Identification of a Population with Probable Advanced Liver Disease:	Baseline	Description: This outcome will estimate the prevalence of advanced liver disease using the Forns Score.; Assessment Methods: The Forns Score will be applied to identify individuals at high risk of fibrosis.; FORNS calculation utilizes the following formula : \[7.811 - 3.131 × ln \[number of platelets\] × 0.781 ln \[GGTP (U/L)\] + 3.467 × ln \[age (years)\] - 0.014 \[cholesterol (mg/dL)\]\\\].; Risk Classification: Low Risk: Forns Score \<4.2 (rules out significant fibrosis, ≥F2) High Risk: Forns Score \>6.9 (indicates significant fibrosis, ≥F2); Unit of Measure: Percentage of participants; Time Frame: Baseline
Identification of Potential Factors Associated with advanced liver disease.	Baseline	This outcome will analyze demographic, metabolic, and lifestyle variables associated with the presence of viral hepatitis.; Assessment Methods: Multivariable logistic regression will be used to assess associations between hepatitis status and: Demographics: Age, sex, socioeconomic status Metabolic risk factors: Obesity (BMI, WHR), diabetes (HbA1c, fasting glucose) Lifestyle: Smoking status, alcohol consumption, physical activity Outcome Measurement: Identification of significant predictors of hepatitis using adjusted odds ratios and confidence intervals.

Trial Locations

Locations (2)

Transylvania University School of Medicine; 🇷🇴 Brasov, Romania

National Institute for Public Health; 🇷🇴 Bucharest, Romania