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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Coimbra Pediatric Hospital - CHUC

Coimbra, 3000-602, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;

Exclusion criteria

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

Treatment and study plan

Blood and urine samples collection

Diagnostic Test

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.

Primary outcomes

Urine miRNAs extracellular vesicles molecular signatures for the study groups

Time frame: 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

Time frame: October/23 until July/2024

Characterize blood miRNAs extracellular vesicles molecular signatures for the study groups

Sponsors and collaborators

Lead sponsor

Unidade Local de Saúde de Coimbra, EPE

Other

Collaborators

Università di Siena

Registry information

Acronym: EvsBioDiabetes

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2027
First posted: Feb 18, 2025
Registry last updated: Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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