NCT07181018招募中不适用
Multimorbidity in Metabolic Syndrome: A Longitudinal Cohort Study in TWINS.PL
Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- De novo occurrence of metabolic steatosis, hepatic fibrosis, or cirrhosis.
研究概览
简要总结
Over a 5-year follow-up period, we aim to conduct a study among twins aged 15-44 years from the Polish population with the following objectives:
- To determine the incidence and risk factors for the development of de novo metabolic dysfunction-associated steatotic liver disease (MASLD), liver fibrosis, or cirrhosis. We also intend to evaluate the progression of hepatic steatosis from early to advanced stages or toward fibrosis/cirrhosis.
- To determine the prevalence and identify predictive factors for the onset and progression of features, diseases, or complications of metabolic syndrome (MS) other than liver disease, particularly within the spectrum of metabolic, nutritional, cardiovascular, endocrine, oncological, psychological, and other disorders typically associated with MS.
- To assess the association between previous COVID-19 infection or long-COVID features and the occurrence of MASLD, liver fibrosis, or cirrhosis due to MASLD, as well as other features, diseases, or complications of MS.
- To evaluate the prevalence of malignancies in a young twin population (aged 15-44 years) with MS or with risk factors for MS.
- To investigate the contribution of genetic and environmental factors and gut microbiota composition to the development and progression of structural liver changes (steatosis, fibrosis, cirrhosis) in MASLD, as well as other features and complications of MS in twins discordant for the MS phenotype.
- To assess the role of genetic and environmental components in the occurrence and severity of MS phenotype discordance in monozygotic twins.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 44 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
De novo occurrence of metabolic steatosis, hepatic fibrosis, or cirrhosis.
时间窗: Baseline up to approximately 5 years
De novo occurrence of metabolic steatosis, hepatic fibrosis, or cirrhosis based on assessment by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) and/or transient elastography.
Progression of hepatic steatosis or fibrosis to more advanced stages or cirrhosis.
时间窗: Baseline up to approximately 5 years
Progression of hepatic steatosis or fibrosis to more advanced stages or cirrhosis, as assessed by magnetic resonance imaging and dynamic elastography, using the following evaluation scales: * The hepatic steatosis grading scale based on magnetic resonance imaging-proton density fat fraction (MRI-PDFF); * The hepatic steatosis grading scale based on dynamic elastography using the Controlled Attenuation Parameter (CAP) technique; * The liver fibrosis grading scale assessed by dynamic elastography using liver stiffness (LS) measurement, according to the METAVIR scoring system
次要结局
- First-time occurrence of Acute coronary syndrome, the need for coronary artery bypass grafting (CABG), any percutaneous coronary intervention (PCI), or detection of regional wall motion abnormalities on echocardiography(Baseline to approximately 5 years)
- First-time occurrence of overweight or obesity(Baseline to approximately 5 years)
- First-time occurrence of an increase in visceral adipose tissue(Baseline to approximately 5 years)
- First-time occurrence of Prediabetes or type 2 diabetes mellitus (T2DM)(Baseline to approximately 5 years)
- The assessment of HOMA-IR(Baseline to approximately 5 years)
- First-time occurrence of Pancreatic steatosis(Baseline to approximately 5 years)
- First-time occurrence of Hypertension (HTN)(Baseline to approximately 5 years)
- First-time occurrence of Systolic heart failure with a reduced left ventricular ejection fraction of less than 45%(Baseline to approximately 5 years)
- First-time occurrence of Atrial fibrillation/flutter(Baseline to approximately 5 years)
- First-time occurrence of Requirement for angioplasty, stenting, or surgery of the aorta or any other arteries (excluding trauma-related causes)(Baseline to approximately 5 years)
- First-time occurrence of Implantation of a cardiac electronic device(Baseline to approximately 5 years)
- First-time occurrence of Transient ischemic attack (TIA) or ischemic stroke(Baseline to approximately 5 years)
- First-time occurrence of Hashimoto's thyroiditis(Baseline to approximately 5 years)
- First-time occurrence of Focal thyroid lesions detected on ultrasound(Baseline to approximately 5 years)
- First-time occurrence of Adrenal incidentaloma(Baseline to approximately 5 years)
- First-time occurrence of Malignancy with a known potential association with insulin resistance(Baseline to approximately 5 years)
- First-time occurrence of Long COVID-19 syndrome(Baseline to approximately 5 years)
- Death from non-accidental causes(Baseline to approximately 5 years)
- The assessment of HbA1c(Baseline to approximately 5 years)
研究者
研究点 (1)
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