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

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

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus

Treatments: Diagnostic Test: Blood and urine samples collection

Study type: Observational

Funder types: Other

Identifiers

NCT06832215

OBS.SF.05.2023

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

Type 1 Diabetes Group

Description:

Type 1 Diabetes people under 18 years´old

Treatment:

Diagnostic Test: Blood and urine samples collection

Genetic-related Group

Description:

Brothers/sisters of T1D children and adolescents (without disease)

Treatment:

Diagnostic Test: Blood and urine samples collection

Control group

Description:

Not genetic related and no T1D people under 18 years' old

Treatment:

Diagnostic Test: Blood and urine samples collection