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临床试验/NCT06832215
NCT06832215进行中(未招募)不适用

Urine Extracellular Vesicles: Non-invasive Biomarkers of Β-cell Function and Novel Therapeutic Agents in Diabetes

Centro Hospitalar e Universitário de Coimbra, E.P.E.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月6日最近更新:
适应症

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

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

发起方
Centro Hospitalar e Universitário de Coimbra, E.P.E.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joana Serra Caetano

MD, Consultant in Pediatrics (Graduated), Pediatric Endocrinologist and Diabetologist

Centro Hospitalar e Universitário de Coimbra, E.P.E.

研究点 (1)

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