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NCT06832215

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

Sponsor: Unidade Local de Saúde de Coimbra, EPE

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2023-05-06

Completion Date

2027-03-30

Last Updated

2025-02-18

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Coimbra Pediatric Hospital - CHUC

Coimbra, Portugal