ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study

NCT07336563 | Not Yet Recruiting DMC

• 1 other identifier: ENDOCARE_23/BNBO/2025
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

MASLD; MAFLD; Metabolic syndrome; Liver steatosis; Screening; Ultrasound; Metabolic health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Association between MAFLD and metabolic syndrome burden

  Baseline

• Association between MAFLD and anthropometric parameters

  Baseline

• Association between MAFLD and glycemic status

  Baseline

• Association between MAFLD and lipid profile

  Baseline

• Independent predictors of MAFLD and moderate-to-severe steatosis

  Baseline

Other Outcomes (3)

• Behavioral and motivational profiles related to MAFLD

  Baseline

• Awareness of fatty liver and readiness to change lifestyle

  Baseline

• Acceptance and needs regarding digital health/app features

  Baseline

Study Arms (1)

Group 1

Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with potential MAFLD/MASLD syndrome

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jarosław Drobnik: lead

Study Sites (1)

ENDOCARE

Wroclaw, 50-558, Poland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Obesity; Overweight; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jarosław Drobnik, Prof. MD, PhD

  ENDOCARE Medical Center in Wroclaw, POLAND

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Tejza, MSc

CONTACT

71 726 67 00; k.tejza@endocare.wroclaw.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)