NCT06832215

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Unidade Local de Saúde de Coimbra, EPE · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood and urine samples collection	Blood and urine were collected at a single time point for all participants, from the tree study groups. Fasting for blood collection and the first urine in the morning were required.

Timeline

• Start date: 2023-05-06
• Primary completion: 2023-10-15
• Completion: 2027-03-30
• First posted: 2025-02-18
• Last updated: 2025-02-18

Locations

1 site across 1 country: Portugal