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Набор скоро начнётся NCT07336563

ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH), Metabolic Syndrome, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
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Официальное название

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)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Prevalence of MAFLD/MASLD [Срок оценки: Baseline (single screening visit)]
  • Distribution of hepatic steatosis severity on liver ultrasound [Срок оценки: Baseline (single screening visit)]
Вторичные конечные точки (7)
  • Association between MAFLD and metabolic syndrome burden [Срок оценки: Baseline]
  • Association between MAFLD and anthropometric parameters [Срок оценки: Baseline]
  • Association between MAFLD and glycemic status [Срок оценки: Baseline]
  • Association between MAFLD and lipid profile [Срок оценки: Baseline]
  • Independent predictors of MAFLD and moderate-to-severe steatosis [Срок оценки: Baseline]
  • Previously undiagnosed MAFLD/liver disease [Срок оценки: Baseline]
  • Eligibility yield for the interventional stage [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Польша · 1 центр
  • ENDOCARE — Wroclaw

Идентификаторы

NCT: NCT07336563 · ENDOCARE_23/BNBO/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗