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NCT Number: NCT07336563

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.

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Key information

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) Body Weight Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Resistance Syndrome Liver Diseases Metabolic Diseases Metabolic Syndrome Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Obesity Type 2 Diabetes Mellitus Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ENDOCARE

Wroclaw, 50-558, Poland

Location contact

Jarosław Drobnik, Prof. MD, PhD

PRINCIPAL_INVESTIGATOR

Katarzyna Tejza, MSc

CONTACT

[email protected]

71 726 67 00 ext. +48

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of MAFLD/MASLD

    Time frame: Baseline (single screening visit)

    Proportion of participants meeting MAFLD/MASLD criteria according to current definitions

  2. Distribution of hepatic steatosis severity on liver ultrasound

    Time frame: Baseline (single screening visit)

    Ultrasound steatosis grade (0-3): mild (1), moderate (2), severe (3).

Secondary outcomes

  1. Association between MAFLD and metabolic syndrome burden

    Time frame: Baseline

    Relationship between MAFLD status and number of metabolic syndrome components

  2. Association between MAFLD and anthropometric parameters

    Time frame: Baseline

    Relationship between MAFLD and body mass index (BMI) and waist circumference

  3. Association between MAFLD and glycemic status

    Time frame: Baseline

    Relationship between MAFLD and diabetes/prediabetes markers (e.g., fasting glucose/HbA1c as collected)

  4. Association between MAFLD and lipid profile

    Time frame: Baseline

    Relationship between MAFLD and lipid parameters as collected in routine labs

  5. Independent predictors of MAFLD and moderate-to-severe steatosis

    Time frame: Baseline

    Multivariable models (e.g., logistic regression) identifying predictors of MAFLD and moderate-to-severe steatosis

  6. Previously undiagnosed MAFLD/liver disease

    Time frame: Baseline

    Proportion of participants with newly identified MAFLD/liver abnormalities during screening

  7. Eligibility yield for the interventional stage

    Time frame: Baseline

    Proportion of screened participants meeting pre-defined qualification criteria for the second stage (ENDOCARE-SUPPORT)

Other outcomes

  1. Behavioral and motivational profiles related to MAFLD

    Time frame: Baseline

    Lifestyle clusters (diet, physical activity, stimulants) in relation to MAFLD presence

  2. Awareness of fatty liver and readiness to change lifestyle

    Time frame: 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)

  3. Acceptance and needs regarding digital health/app features

    Time frame: Baseline

    Self-reported preferences to inform ENDOCARE app development

Study contacts

Contact information is provided by the study sponsor or research team.

Katarzyna Tejza, MSc

CONTACT

[email protected]

71 726 67 00 ext. +48

Sponsors and collaborators

Lead sponsor

Jarosław Drobnik

Other

Registry information

Official study title

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)

Acronym: ENDOCARE-SCREE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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