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ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study

NCT07336563 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2026-01-15

No results posted yet for this study

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

Sponsors & Collaborators

  • Jarosław Drobnik

    lead OTHER

Principal Investigators

  • Jarosław Drobnik, Prof. MD, PhD · ENDOCARE Medical Center in Wroclaw, POLAND

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07336563 on ClinicalTrials.gov