Diabetes Mellitus, Type 1, Diabetes Mellitus
Conditions
Keywords
Non-invasive biomarker of beta cell function in urine
Brief 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.
Interventions
DIAGNOSTIC_TESTBlood 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.
Sponsors
Università di Siena
Unidade Local de Saúde de Coimbra, EPE
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine miRNAs extracellular vesicles molecular signatures for the study groups | 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 | October/23 until July/2024 | Characterize blood miRNAs extracellular vesicles molecular signatures for the study groups |
Countries
Portugal
Outcome results
None listed