Diabetes Mellitus, Type 1EvsBioDiabetesNCT06832215
Urine Extracellular Vesicles: Non-invasive Biomarkers of Β-cell Function and Novel Therapeutic Agents in Diabetes
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus
- What is being tested?
- Blood and urine samples collection
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 6 May 2023to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and adolescents under follow-up at Coimbra Pediatric Hospital - Coimbra University and Hospital Centre (CHUC), either in specific clinic (Diabetes - for T1D group) or that have been observed at a general endocrine or pediatrics clinics for a suspition of disease that was not confirmed (for control group). For the genetic related group, children and adolescents were recruited within T1D families and were observed in a single time point, at the time of their brother/sister.
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus
- Being tested
- Blood and urine samples collection
- Keywords
- Non-invasive biomarker of beta cell function in urine
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine samples collectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes Group | Type 1 Diabetes people under 18 years´old Receives: Diagnostic Test: Blood and urine samples collection | |
| Genetic-related Group | Brothers/sisters of T1D children and adolescents (without disease) Receives: Diagnostic Test: Blood and urine samples collection | |
| Control group | Not genetic related and no T1D people under 18 years' old Receives: Diagnostic Test: Blood and urine samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine miRNAs extracellular vesicles molecular signatures for the study groups
Characterize urine EV-derived miRNAs in the three study groups
Measured: October/23 until July/2024
Blood miRNAs extracellular vesicles molecular signatures for the study groups
Characterize blood miRNAs extracellular vesicles molecular signatures for the study groups
Measured: October/23 until July/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start6 May 2023
- Primary completion15 Oct 2023
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Collaborators
- Università di Siena
- Responsible party
- Principal investigator, Joana Serra Caetano, Unidade Local de Saúde de Coimbra, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832215
- Sponsor's protocol ID
- OBS.SF.05.2023
- Acronym
- EvsBioDiabetes
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential information collected with permission for this study purpose but not to share with other studies
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Extracellular Vesicles: Non-invasive Biomarkers of Β-cell Function and Novel Therapeutic Agents in Diabetes
- ClinicalTrials.gov ID
- NCT06832215
- Acronym / sponsor ID
- EvsBioDiabetes / OBS.SF.05.2023
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus
- Keywords
- Non-invasive biomarker of beta cell function in urine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Collaborators
- Università di Siena
- Study start
- 6 May 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes Group | – | Diagnostic Test: Blood and urine samples collectionType 1 Diabetes people under 18 years´old |
| Genetic-related Group | – | Diagnostic Test: Blood and urine samples collectionBrothers/sisters of T1D children and adolescents (without disease) |
| Control group | – | Diagnostic Test: Blood and urine samples collectionNot genetic related and no T1D people under 18 years' old |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents under follow-up at Coimbra Pediatric Hospital - Coimbra University and Hospital Centre (CHUC), either in specific clinic (Diabetes - for T1D group) or that have been observed at a general endocrine or pediatrics clinics for a suspition of disease that was not confirmed (for control group). For the genetic related group, children and adolescents were recruited within T1D families and were observed in a single time point, at the time of their brother/sister.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine samples collectionBlood 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. | Diagnostic test | Control group, Genetic-related Group, Type 1 Diabetes Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No. Confidential information collected with permission for this study purpose but not to share with other studies
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine miRNAs extracellular vesicles molecular signatures for the study groups (time frame: October/23 until July/2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.