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.
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
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.
People with potential MAFLD/MASLD syndrome
Cohort
Cross-sectional
Not listed
Prevalence of MAFLD/MASLD
Proportion of participants meeting MAFLD/MASLD criteria according to current definitions
Distribution of hepatic steatosis severity on liver ultrasound
Ultrasound steatosis grade (0-3): mild (1), moderate (2), severe (3).
Association between MAFLD and metabolic syndrome burden
Relationship between MAFLD status and number of metabolic syndrome components
Association between MAFLD and anthropometric parameters
Relationship between MAFLD and body mass index (BMI) and waist circumference
Association between MAFLD and glycemic status
Relationship between MAFLD and diabetes/prediabetes markers (e.g., fasting glucose/HbA1c as collected)
Association between MAFLD and lipid profile
Relationship between MAFLD and lipid parameters as collected in routine labs
Behavioral and motivational profiles related to MAFLD
Lifestyle clusters (diet, physical activity, stimulants) in relation to MAFLD presence
Awareness of fatty liver and readiness to change lifestyle
Self-reported awareness of fatty liver disease and readiness to change lifestyle assessed using a structured study-specific ENDOCARE Lifestyle Awareness and Readiness Questionnaire (score 0-10: higher scores indicate greater awareness of fatty liver disease and higher readiness to implement lifestyle changes)
Acceptance and needs regarding digital health/app features
Self-reported preferences to inform ENDOCARE app development
Click on the lead sponsor to view all of their trials.
Jarosław Drobnik
Lead sponsor
Endocare, Poland
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
