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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Prevalence of MAFLD/MASLD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Group 1
Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease
结局指标
主要结局
Prevalence of MAFLD/MASLD
时间窗: Baseline (single screening visit)
Proportion of participants meeting MAFLD/MASLD criteria according to current definitions
Distribution of hepatic steatosis severity on liver ultrasound
时间窗: Baseline (single screening visit)
Ultrasound steatosis grade (0-3): mild (1), moderate (2), severe (3).
次要结局
- Association between MAFLD and metabolic syndrome burden(Baseline)
- Association between MAFLD and anthropometric parameters(Baseline)
- Association between MAFLD and glycemic status(Baseline)
- Association between MAFLD and lipid profile(Baseline)
- Independent predictors of MAFLD and moderate-to-severe steatosis(Baseline)
- Previously undiagnosed MAFLD/liver disease(Baseline)
- Eligibility yield for the interventional stage(Baseline)
研究者
Jarosław Drobnik
Prof.
Endocare, Poland