Urine Extracellular Vesicles: Non-invasive Biomarkers of Β-cell Function and Novel Therapeutic Agents in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Urine miRNAs extracellular vesicles molecular signatures for the study groups
研究概览
简要总结
Diabetes mellitus is a common chronic disease with a huge socioeconomic burden worldwide. Type 1 Diabetes(T1D) accounts for nearly 95% of diabetes in pediatric age and a lifelong dependence on exogenous insulin. Its diagnosis is based on symptoms and/or autoantibodies, both identified too late to avoid the disease progress. Ideally, children should be screened whilst assymptomatic, when there is endogenous insulin production, but C-peptide and beta-cell function are starting to decline. Early diagnosis would allow interventions capable of preventing disease progress and/or to preserve beta-cell function, ultimately delaying/avoiding insulin dependence. Given their association with pathogenesis of diabetes, Extracellular Vesicles have emerged as potential biomarkers for diagnosis and progression of diabetes. This project proposes the development of a non-invasive biomarker of preclinical T1D, based on miRNA characterization in urine, allowing a timely identification of children that can benefit from preventive therapies and, in the future, to cure T1D.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •T1D Group: children diagnosed with T1D, according to internationally defined criteria, with at least one positive pancreatic antibody and under functional insulin.
- •Genetic-related group: children without T1D, age- and sex-matched with T1D group, recruited among T1D relatives;
- •Control group: children without T1D, age- and sex-matched with T1D group, recruited from general endocrinology clinics, among children without disease or genetic relation with T1D children;
排除标准
- •Obesity, according to WHO standards for pediatrics;
- •Hypertension, as ≥95th percentile according to International Consensus;
- •Other auto-immune diseases;
- •Diabetes in the context of syndromic features/secondary to treatments;
- •Hypothyroidism, adrenal insufficiency or hypercortisolism;
- •Children under somatotropin/oncologic treatment;
- •Under medications affecting glucose metabolism
结局指标
主要结局
Urine miRNAs extracellular vesicles molecular signatures for the study groups
时间窗: October/23 until July/2024
Characterize urine EV-derived miRNAs in the three study groups
Blood miRNAs extracellular vesicles molecular signatures for the study groups
时间窗: October/23 until July/2024
Characterize blood miRNAs extracellular vesicles molecular signatures for the study groups
次要结局
未报告次要终点
研究者
Joana Serra Caetano
MD, Consultant in Pediatrics (Graduated), Pediatric Endocrinologist and Diabetologist
Centro Hospitalar e Universitário de Coimbra, E.P.E.
