Diabetes Mellitus, Type 1NCT06325111
Determinants of Glycaemic Control in Children With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 29 May 2023to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: T1D subjects (children and young adults) attending to several Diabetes Units of Italian and European institutions
Who may be able to join
- Type 1 diabetes subjects
- Age from 6 to 20 years old
- At least 5 years of duration of disease
Who cannot join
- Type 1 diabetes subjects incapable of giving valid informed consent or whose parents are incapable of giving valid informed consent.
- Type 1 diabetes subjects for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
- Subjects with other types of diabetes (i.e. type 2, monogenic diabetes, cystic fibrosis related diabetes)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Eulalia Catamo, BSc, +39 040.3785470, eulalia.catamo@burlo.trieste.it
About this study
Official title: Exploring Genetic, Epigenetic and Environmental Determinants of Glycaemic Control in Children and Young Individuals With Type 1 Diabetes
Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.
While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.
However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic control.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Determinants of T1D glycaemic control
- Keywords
- Type 1 Diabetes glycaemic control, Epigenetic modifications, Diabetes-related complications
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determinants of T1D glycaemic controlOther
DNA genotyping, microbiome, DNA methylation and microRNAs analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with T1D and optimal glycaemic control | Optimal glycaemic control will be defined as HbA1c values <7% Receives: Other: Determinants of T1D glycaemic control | |
| Patients with T1D and poor glycaemic control | Poor glycemic control will be defined as HbA1c value ≥7% Receives: Other: Determinants of T1D glycaemic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genes involved in T1D glycaemic control
DNA will be isolated from saliva by Genefix Saliva DNA/RNA collection kit (Isohelix, UK) and whole genome genotyping will be performed using Illumina chip arrays (CA, USA).
Measured: Through study completion, an average of 18 months
Identification of DNA methylation patterns involved in T1D glycaemic control
Peripheral blood will be collected from each participant into EDTA-containing tubes and Genome-wide DNA methylation will be performed using the Illumina Infinium Human Methylation EPIC BeadChip array
Measured: Through study completion, an average of 18 months
Identification of microRNAs involved in T1D glycaemic control
Peripheral blood will be collected from each participant into Ethylenediaminetetraacetic acid (EDTA)-containing tubes for microRNAs sequencing. Illumina TruSeq Small RNA Sample Preparation kit will be used for library preparation, and sequencing will be conducted by Illumina platform (CA, USA).
Measured: Through study completion, an average of 18 months
Identification of oral microbiome characteristics associated to T1D glycaemic control
Bacterial DNA will be extracted from saliva and a 500 base pair region of the V1-V3 portion of the 16S ribosomal RNA gene as well as the 200 base pair region of the V3 portion will be amplified. The V3 amplicon will be used for template preparation and will be sequenced using the Ion PGM Hi-Q View sequencing kit (Life Technologies, New York, NY, USA) with the IonPGM™System technology
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start29 May 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325111
- Sponsor's protocol ID
- RC 06/2023
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Genetic, Epigenetic and Environmental Determinants of Glycaemic Control in Children and Young Individuals With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06325111
- Acronym / sponsor ID
- RC 06/2023
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes glycaemic control, Epigenetic modifications, Diabetes-related complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Mar 2024 (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.
Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.
While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.
However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic control.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with T1D and optimal glycaemic control | – | Other: Determinants of T1D glycaemic controlOptimal glycaemic control will be defined as HbA1c values <7% |
| Patients with T1D and poor glycaemic control | – | Other: Determinants of T1D glycaemic controlPoor glycemic control will be defined as HbA1c value ≥7% |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- T1D subjects (children and young adults) attending to several Diabetes Units of Italian and European institutions
Key inclusion criteria (3 listed)
- Type 1 diabetes subjects
- Age from 6 to 20 years old
- At least 5 years of duration of disease
Key exclusion criteria (3 listed)
- Type 1 diabetes subjects incapable of giving valid informed consent or whose parents are incapable of giving valid informed consent.
- Type 1 diabetes subjects for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
- Subjects with other types of diabetes (i.e. type 2, monogenic diabetes, cystic fibrosis related diabetes)
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 |
|---|---|---|
| Determinants of T1D glycaemic controlDNA genotyping, microbiome, DNA methylation and microRNAs analysis | Other | Patients with T1D and optimal glycaemic control, Patients with T1D and poor glycaemic control |
Primary outcome
Identification of genes involved in T1D glycaemic control
Time frame: Through study completion, an average of 18 months
DNA will be isolated from saliva by Genefix Saliva DNA/RNA collection kit (Isohelix, UK) and whole genome genotyping will be performed using Illumina chip arrays (CA, USA).
Identification of DNA methylation patterns involved in T1D glycaemic control
Time frame: Through study completion, an average of 18 months
Peripheral blood will be collected from each participant into EDTA-containing tubes and Genome-wide DNA methylation will be performed using the Illumina Infinium Human Methylation EPIC BeadChip array
Identification of microRNAs involved in T1D glycaemic control
Time frame: Through study completion, an average of 18 months
Peripheral blood will be collected from each participant into Ethylenediaminetetraacetic acid (EDTA)-containing tubes for microRNAs sequencing. Illumina TruSeq Small RNA Sample Preparation kit will be used for library preparation, and sequencing will be conducted by Illumina platform (CA, USA).
Identification of oral microbiome characteristics associated to T1D glycaemic control
Time frame: Through study completion, an average of 18 months
Bacterial DNA will be extracted from saliva and a 500 base pair region of the V1-V3 portion of the 16S ribosomal RNA gene as well as the 200 base pair region of the V3 portion will be amplified. The V3 amplicon will be used for template preparation and will be sequenced using the Ion PGM Hi-Q View sequencing kit (Life Technologies, New York, NY, USA) with the IonPGM™System technology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
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, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eulalia Catamo, BSc (040.3785470, eulalia.catamo@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genes involved in T1D glycaemic control (time frame: Through study completion, an average of 18 months). The study lists 4 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 22 Mar 2024.