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

January 13, 2026 updated by: Jarosław Drobnik

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Wroclaw, Poland, 50-558
        • Endocare
        • Contact:
        • Principal Investigator:
          • Jarosław Drobnik, Prof. MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group 1
Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of MAFLD/MASLD
Time Frame: Baseline (single screening visit)
Proportion of participants meeting MAFLD/MASLD criteria according to current definitions
Baseline (single screening visit)
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).
Baseline (single screening visit)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association between MAFLD and metabolic syndrome burden
Time Frame: Baseline
Relationship between MAFLD status and number of metabolic syndrome components
Baseline
Association between MAFLD and glycemic status
Time Frame: Baseline
Relationship between MAFLD and diabetes/prediabetes markers (e.g., fasting glucose/HbA1c as collected)
Baseline
Association between MAFLD and lipid profile
Time Frame: Baseline
Relationship between MAFLD and lipid parameters as collected in routine labs
Baseline
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
Baseline
Previously undiagnosed MAFLD/liver disease
Time Frame: Baseline
Proportion of participants with newly identified MAFLD/liver abnormalities during screening
Baseline
Eligibility yield for the interventional stage
Time Frame: Baseline
Proportion of screened participants meeting pre-defined qualification criteria for the second stage (ENDOCARE-SUPPORT)
Baseline
Association between MAFLD and anthropometric parameters
Time Frame: Baseline
Relationship between MAFLD and body mass index (BMI) and waist circumference
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioral and motivational profiles related to MAFLD
Time Frame: Baseline
Lifestyle clusters (diet, physical activity, stimulants) in relation to MAFLD presence
Baseline
Acceptance and needs regarding digital health/app features
Time Frame: Baseline
Self-reported preferences to inform ENDOCARE app development
Baseline
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)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jarosław Drobnik

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jarosław Drobnik, Prof. MD, PhD, ENDOCARE Medical Center in Wroclaw, POLAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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