ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study

Jarosław Drobnik

Status: Not yet enrolling

Conditions: Obesity & Overweight; Insulin Resistance Syndrome; Obesity Type 2 Diabetes Mellitus; Metabolic Syndrome; Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH)

Study type: Observational

Funder types: Other

Identifiers

NCT07336563

ENDOCARE_23/BNBO/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10,000 participants in 1 patient group

Group 1

Description:

Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease