Risk of MASLD in Adults in Romania (MASLD Ro)

March 9, 2025 updated by: Internist.Ro

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)

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

5340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Brasov, Romania, 500019
        • Transylvania University School of Medicine
      • Bucharest, Romania, 050463
        • National Institute for Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MASLD-At-Risk Cohort
Individuals meeting MASLD criteria based on metabolic dysfunction risk factors and hepatic steatosis.
MASH Cohort
Subgroup with MASLD who meet additional criteria for hepatic inflammation and fibrosis risk.
Alcohol-Related Liver Disease (ALD) Cohort:
Participants exceeding alcohol consumption thresholds who exhibit liver dysfunction and no other risk factors for liver diseas
MetALD Cohort:
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
Participants with no significant metabolic dysfunction and normal liver function and no other risk factors for liver disease serving as a reference population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Definition of an at-risk for MASLD population in Romania based on metabolic and hepatic risk factors.
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Patients with Known Liver Disease
Time Frame: 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
Baseline
Identification of a Population with Probable Advanced Liver Disease:
Time Frame: 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
Baseline
Identification of Potential Factors Associated with advanced liver disease.
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Internist.Ro

Collaborators

Transilvania University of Brasov

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A002
  • PDP1/NT2311/13.05.2020 (Other Identifier: EEA Grants/Norway Grants under the Financial Mechanism 2014-2021,)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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