NCT06832215Active, not recruiting
Urine Extracellular Vesicles: Non-invasive Biomarkers of Β-cell Function and Novel Therapeutic Agents in Diabetes
Source: ClinicalTrials.gov · Last updated 18 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 120 (actual)
- First submitted
- 12 Feb 2025
- Start date
- 6 May 2023
- Primary completion date
- 15 Oct 2023
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Diseases
- Type 1 diabetes
- NCT number
- NCT06832215
What you commit to
- Study type: Observational
- Participants enrolled: 120
- From 6 May 2023 to the primary completion date, 15 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Lab values
- Under medications affecting glucose metabolism
Other
- Obesity, according to WHO standards for pediatrics;
- Children under somatotropin/oncologic treatment;
Who the study is looking for
- 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;
Age in the registry: - to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Coimbra Pediatric Hospital - CHUC Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.