Clinical Trial

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

Study acronym: EvsBioDiabetes
Active, Not Recruiting
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Summary
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.
Trial Details
NCT Number NCT06832215
Lead Sponsor Unidade Local de Saúde de Coimbra, EPE
Collaborators: Università di Siena
Conditions Diabetes Mellitus, Type 1, Diabetes Mellitus
Enrollment 120 participants
Start Date 2023-05-06
Primary Completion 2023-10-15 (estimated)
Study Completion 2027-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-18