Insulin Resistance Syndrome, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH), Metabolic Syndrome, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus
Conditions
Keywords
MASLD, MAFLD, Metabolic syndrome, Liver steatosis, Screening, Ultrasound, Metabolic health
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.
Interventions
None listed
Sponsors
Jarosław Drobnik
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of MAFLD/MASLD | Baseline (single screening visit) | Proportion of participants meeting MAFLD/MASLD criteria according to current definitions |
| Distribution of hepatic steatosis severity on liver ultrasound | Baseline (single screening visit) | Ultrasound steatosis grade (0-3): mild (1), moderate (2), severe (3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between MAFLD and anthropometric parameters | Baseline | Relationship between MAFLD and body mass index (BMI) and waist circumference |
| Association between MAFLD and glycemic status | Baseline | Relationship between MAFLD and diabetes/prediabetes markers (e.g., fasting glucose/HbA1c as collected) |
| Association between MAFLD and lipid profile | Baseline | Relationship between MAFLD and lipid parameters as collected in routine labs |
| Association between MAFLD and metabolic syndrome burden | Baseline | Relationship between MAFLD status and number of metabolic syndrome components |
| Independent predictors of MAFLD and moderate-to-severe steatosis | Baseline | Multivariable models (e.g., logistic regression) identifying predictors of MAFLD and moderate-to-severe steatosis |
| Previously undiagnosed MAFLD/liver disease | Baseline | Proportion of participants with newly identified MAFLD/liver abnormalities during screening |
| Eligibility yield for the interventional stage | Baseline | Proportion of screened participants meeting pre-defined qualification criteria for the second stage (ENDOCARE-SUPPORT) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Behavioral and motivational profiles related to MAFLD | Baseline | Lifestyle clusters (diet, physical activity, stimulants) in relation to MAFLD presence |
| Awareness of fatty liver and readiness to change lifestyle | Baseline | 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 | Baseline | Self-reported preferences to inform ENDOCARE app development |
Countries
Poland
Contacts
Primary ContactKatarzyna Tejza, MSc
Outcome results
None listed