ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study (ENDOCARE-SCREE)

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome; Insulin Resistance Syndrome; Obesity & Overweight; Obesity Type 2 Diabetes Mellitus; Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH)

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Katarzyna Tejza, MSc; Phone Number: +48 71 726 67 00; Email: k.tejza@endocare.wroclaw.pl

Study Locations

• Poland
  • Wroclaw, Poland, 50-558
    • Endocare
    • Contact: Katarzyna Tejza, MSc; Phone Number: +48 71 726 67 00; Email: k.tejza@endocare.wroclaw.pl
    • Principal Investigator: Jarosław Drobnik, Prof. MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People with potential MAFLD/MASLD syndrome

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Group 1; Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of MAFLD/MASLD	Proportion of participants meeting MAFLD/MASLD criteria according to current definitions	Baseline (single screening visit)
Distribution of hepatic steatosis severity on liver ultrasound	Ultrasound steatosis grade (0-3): mild (1), moderate (2), severe (3).	Baseline (single screening visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between MAFLD and metabolic syndrome burden	Relationship between MAFLD status and number of metabolic syndrome components	Baseline
Association between MAFLD and glycemic status	Relationship between MAFLD and diabetes/prediabetes markers (e.g., fasting glucose/HbA1c as collected)	Baseline
Association between MAFLD and lipid profile	Relationship between MAFLD and lipid parameters as collected in routine labs	Baseline
Independent predictors of MAFLD and moderate-to-severe steatosis	Multivariable models (e.g., logistic regression) identifying predictors of MAFLD and moderate-to-severe steatosis	Baseline
Previously undiagnosed MAFLD/liver disease	Proportion of participants with newly identified MAFLD/liver abnormalities during screening	Baseline
Eligibility yield for the interventional stage	Proportion of screened participants meeting pre-defined qualification criteria for the second stage (ENDOCARE-SUPPORT)	Baseline
Association between MAFLD and anthropometric parameters	Relationship between MAFLD and body mass index (BMI) and waist circumference	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral and motivational profiles related to MAFLD	Lifestyle clusters (diet, physical activity, stimulants) in relation to MAFLD presence	Baseline
Acceptance and needs regarding digital health/app features	Self-reported preferences to inform ENDOCARE app development	Baseline
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)	Baseline

Collaborators and Investigators

• Sponsor: Jarosław Drobnik
• Investigators: Principal Investigator: Jarosław Drobnik, Prof. MD, PhD, ENDOCARE Medical Center in Wroclaw, POLAND

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: January 2, 2026
• First Posted (Estimated): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Metabolic syndrome; Screening; Liver steatosis; Metabolic health; MAFLD; MASLD
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Digestive System Diseases; Glucose Metabolism Disorders; Liver Diseases; Insulin Resistance; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Metabolic Syndrome; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ENDOCARE_23/BNBO/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly. De-identified aggregated results may be shared in scientific publications and conference presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No