ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study

Sponsor
Jarosław Drobnik
Study ID
NCT07336563
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jan 13, 2026
Start date
Jan 5, 2026
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: Group 1
    Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease

Primary Outcome Measure

Prevalence of MAFLD/MASLD [ Time Frame: Baseline (single screening visit) ]

Central Contacts

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