Diabetes Mellitus, Type 1NCT06317454
Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 1, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence… Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Blood and saliva analysis
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2021to 31 Dec 2024
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients between 6 and 21 years with or without type 1 diabetes
Who may be able to join
- Cases:
- age between 6 and 21 years;
- patients suffering from type 1 diabetes
- Controls:
- age between 6 and 21 years;
- patients for whom a venous sampling is planned
Who cannot join
- Cases:
- patients for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
- patients with other types of diabetes mellitus (type 2, monogenic diabetes, diabetes related to cystic fibrosis...)
- patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.
- Controls:
- subjects with type 1 and 2 diabetes
Show all 9Show fewer
- obese subjects and those with a family history of diabetes and obesity or other metabolic disorders
- subjects with HbA1c >6%
- patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.
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
Antonietta Robino, +39.040.3785.470, antonietta.robino@burlo.trieste.it
Silvia Tommasi, +39.040.3785.863, silvia.tommasi@burlo.trieste.it
About this study
Official title: Genetic and Environmental Determinants of Metabolic Control in Children and Young Adults With Type 1 Diabetes Mellitus
A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic.
While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.
This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Blood and saliva analysis
- Keywords
- Type 1 diabetes, Metabolic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and saliva analysisDiagnostic test
Phenotyping and genotyping characterization using blood and saliva
| Study group | Role | What they receive |
|---|---|---|
| Subjects with T1DM | Not described Receives: Diagnostic Test: Blood and saliva analysis | |
| Control subjects | Not described Receives: Diagnostic Test: Blood and saliva analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of environmental factors affecting T1DM metabolic control
Measured: Through study completion, an average of 18 months
Identification of genetic factors affecting T1DM metabolic control
Identify genetic factors responsible of differences in T1DM metabolic control and thus uncover genes of potential biological therapeutic importance
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 posted19 Mar 2024
- Study start11 Nov 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- Other
- 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
- NCT06317454
- Sponsor's protocol ID
- GR-2019-12369573
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Environmental Determinants of Metabolic Control in Children and Young Adults With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06317454
- Acronym / sponsor ID
- GR-2019-12369573
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes, Metabolic control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 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.
A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic.
While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.
This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with T1DM | – | Diagnostic Test: Blood and saliva analysis |
| Control subjects | – | Diagnostic Test: Blood and saliva analysis |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients between 6 and 21 years with or without type 1 diabetes
Key inclusion criteria (6 listed)
- age between 6 and 21 years;
- patients suffering from type 1 diabetes
- age between 6 and 21 years;
- patients for whom a venous sampling is planned
Key exclusion criteria (9 listed)
- patients for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
- patients with other types of diabetes mellitus (type 2, monogenic diabetes, diabetes related to cystic fibrosis...)
- patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.
- subjects with type 1 and 2 diabetes
- obese subjects and those with a family history of diabetes and obesity or other metabolic disorders
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 saliva analysisPhenotyping and genotyping characterization using blood and saliva | Diagnostic test | Control subjects, Subjects with T1DM |
Primary outcome
Identification of environmental factors affecting T1DM metabolic control
Time frame: Through study completion, an average of 18 months
Identification of genetic factors affecting T1DM metabolic control
Time frame: Through study completion, an average of 18 months
Identify genetic factors responsible of differences in T1DM metabolic control and thus uncover genes of potential biological therapeutic importance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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 6 inclusion and 9 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 19 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 Antonietta Robino (+39.040.785.470, antonietta.robino@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 environmental factors affecting T1DM metabolic control (time frame: Through study completion, an average of 18 months). 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 19 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.