Risk of MASLD in Adults in Romania

NCT06864845 | Completed

• 2 other identifiers: A002PDP1/NT2311/13.05.2020
• Study Type: observational
• Target: 5,340
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

MASH, MASLD, risk, prevalence awareness

Outcome Measures

Primary Outcomes (1)

• Definition of an at-risk for MASLD population in Romania based on metabolic and hepatic risk factors.

  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 Outcomes (3)

• Identification of Patients with Known Liver Disease

  Baseline

• Identification of a Population with Probable Advanced Liver Disease:

  Baseline

• Identification of Potential Factors Associated with advanced liver disease.

  Baseline

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Internist.Ro: lead
• Transilvania University of Brasov: collaborator

Study Sites (2)

Transylvania University School of Medicine

Brasov, Brașov County, 500019, Romania

Location

National Institute for Public Health

Bucharest, Bucharest, 050463, Romania

Location

Related Publications (7)

• Brinduse LA, Eclemea I, Neculau AE, Paunescu BA, Bratu EC, Cucu MA. Rural versus urban healthcare through the lens of health behaviors and access to primary care: a post-hoc analysis of the Romanian health evaluation survey. BMC Health Serv Res. 2024 Nov 4;24(1):1341. doi: 10.1186/s12913-024-11861-9.

  PMID: 39491016 BACKGROUND

• Forns X, Ampurdanes S, Llovet JM, Aponte J, Quinto L, Martinez-Bauer E, Bruguera M, Sanchez-Tapias JM, Rodes J. Identification of chronic hepatitis C patients without hepatic fibrosis by a simple predictive model. Hepatology. 2002 Oct;36(4 Pt 1):986-92. doi: 10.1053/jhep.2002.36128.

  PMID: 12297848 BACKGROUND

• Pimpin L, Cortez-Pinto H, Negro F, Corbould E, Lazarus JV, Webber L, Sheron N; EASL HEPAHEALTH Steering Committee. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies. J Hepatol. 2018 Sep;69(3):718-735. doi: 10.1016/j.jhep.2018.05.011. Epub 2018 May 17.

  PMID: 29777749 BACKGROUND

• Peacock A, Leung J, Larney S, Colledge S, Hickman M, Rehm J, Giovino GA, West R, Hall W, Griffiths P, Ali R, Gowing L, Marsden J, Ferrari AJ, Grebely J, Farrell M, Degenhardt L. Global statistics on alcohol, tobacco and illicit drug use: 2017 status report. Addiction. 2018 Oct;113(10):1905-1926. doi: 10.1111/add.14234. Epub 2018 Jun 4.

  PMID: 29749059 BACKGROUND

• Stival C, Lugo A, Odone A, van den Brandt PA, Fernandez E, Tigova O, Soriano JB, Jose Lopez M, Scaglioni S, Gallus S; TackSHS Project Investigators. Prevalence and Correlates of Overweight and Obesity in 12 European Countries in 2017-2018. Obes Facts. 2022;15(5):655-665. doi: 10.1159/000525792. Epub 2022 Aug 2.

  PMID: 35917801 BACKGROUND

• Younossi ZM. Non-alcoholic fatty liver disease - A global public health perspective. J Hepatol. 2019 Mar;70(3):531-544. doi: 10.1016/j.jhep.2018.10.033. Epub 2018 Nov 9.

  PMID: 30414863 BACKGROUND

• Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.

  PMID: 28930295 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 7, 2025
• Study Start: August 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2)