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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-06

Study Completion Date

2027-03-30

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 1 Diabetes Group

Type 1 Diabetes people under 18 years´old

Blood and urine samples collection

Intervention Type 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.

Genetic-related Group

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

Blood and urine samples collection

Intervention Type 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.

Control group

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

Blood and urine samples collection

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes