Development of a Database of Metabolic Cases and Prevalence of Metabolic Liver Dysfunction (MAFLD/MASLD) in Individuals With Metabolic Syndrome Characteristics - Screening Study (ENDOCARE - SCREEN)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10,000
- Locations
- 2
- Primary Endpoint
- Prevalence of MAFLD/MASLD
Study Overview
Brief Summary
The ENDOCARE-SCREEN study is a single-center, observational, cross-sectional screening study designed to assess the prevalence, phenotypes, and determinants of metabolic dysfunction-associated steatotic liver disease (MASLD/MAFLD) in adults with components of metabolic syndrome. Up to 10,000 participants aged ≥18 years with overweight, obesity, or metabolic risk factors will undergo standardized screening including a health questionnaire, anthropometric measurements, blood pressure assessment, laboratory testing, and liver ultrasound. The study aims to generate a comprehensive metabolic-hepatic dataset integrating clinical, laboratory, imaging, and lifestyle data. Collected data will be used to identify metabolic and behavioral risk factors for MASLD, characterize disease phenotypes, and support the development of predictive models. The ENDOCARE-SCREEN study will also serve as a qualification platform for selecting eligible participants for a subsequent interventional randomized controlled trial (ENDOCARE-SUPPORT). The study involves minimal risk procedures routinely used in clinical practice and follows ethical principles outlined in the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
Detailed Description
Metabolic dysfunction-associated steatotic liver disease (MASLD/MAFLD) is currently the most common chronic liver disease worldwide and represents the hepatic manifestation of metabolic syndrome. Despite its high prevalence, large-scale standardized screening data integrating metabolic, imaging, and lifestyle factors are limited in Central and Eastern Europe. The ENDOCARE-SCREEN study addresses this gap by implementing a structured screening program in a real-world ambulatory population. The study collects detailed sociodemographic, metabolic, behavioral, and imaging data, allowing for comprehensive phenotyping of liver dysfunction in individuals with metabolic risk. In addition to epidemiological objectives, the study assesses participants' readiness for lifestyle modification and digital health tools, supporting the future implementation of personalized, technology-assisted interventions. Data generated in ENDOCARE-SCREEN will inform clinical decision-making, public health strategies, and the design of subsequent interventional studies.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-75 years.
- •Overweight or obesity (BMI ≥ 25 kg/m²) and/or increased waist circumference and/or at least one metabolic risk factor (e.g., hypertension, dyslipidemia, impaired fasting glucose/prediabetes/type 2 diabetes), as applicable per screening program.
- •Participation in the ENDOCARE screening program.
- •Ability to provide written informed consent, including consent for processing health-related data
Exclusion Criteria
- •Inability to provide informed consent (e.g., significant cognitive impairment, acute severe psychiatric disorder, language barrier).
- •Pregnancy or breastfeeding.
- •Known advanced liver diseases at baseline (participants may be excluded from primary analyses and/or described separately, per statistical analysis plan).
- •Refusal of key screening procedures (e.g., blood sampling or liver ultrasound) preventing determination of liver status.
- •Refusal of data processing under General Data Protection Regulation (GDPR) requirements.
Arms & Interventions
Group 1
Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease
Outcomes
Primary Outcomes
Prevalence of MAFLD/MASLD
Time Frame: Baseline (single screening visit)
Proportion of participants meeting MAFLD/MASLD criteria according to current definitions
Distribution of hepatic steatosis severity on liver ultrasound
Time Frame: Baseline (single screening visit)
Ultrasound steatosis grade (0-3): mild (1), moderate (2), severe (3).
Secondary Outcomes
- Association between MAFLD and metabolic syndrome burden(Baseline)
- Association between MAFLD and anthropometric parameters(Baseline)
- Association between MAFLD and glycemic status(Baseline)
- Association between MAFLD and lipid profile(Baseline)
- Independent predictors of MAFLD and moderate-to-severe steatosis(Baseline)
- Previously undiagnosed MAFLD/liver disease(Baseline)
- Eligibility yield for the interventional stage(Baseline)
Investigators
Jarosław Drobnik
Prof.
Endocare, Poland