ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study

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.

NCT Number	NCT07336563
Lead Sponsor	Jarosław Drobnik
Conditions	Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH), Metabolic Syndrome, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Insulin Resistance Syndrome
Enrollment	10,000 participants
Start Date	2026-01-05
Primary Completion	2026-10-31 (estimated)
Study Completion	2026-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-15