ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH), Metabolic Syndrome, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Primary outcome measures
- Prevalence of MAFLD/MASLD [Time frame: Baseline (single screening visit)]
- Distribution of hepatic steatosis severity on liver ultrasound [Time frame: Baseline (single screening visit)]
Secondary outcome measures (7)
- Association between MAFLD and metabolic syndrome burden [Time frame: Baseline]
- Association between MAFLD and anthropometric parameters [Time frame: Baseline]
- Association between MAFLD and glycemic status [Time frame: Baseline]
- Association between MAFLD and lipid profile [Time frame: Baseline]
- Independent predictors of MAFLD and moderate-to-severe steatosis [Time frame: Baseline]
- Previously undiagnosed MAFLD/liver disease [Time frame: Baseline]
- Eligibility yield for the interventional stage [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- ENDOCARE — Wroclaw
Identifiers
NCT: NCT07336563 · ENDOCARE_23/BNBO/2025