Determinants of Glycaemic Control in Children With Type 1 Diabetes
NCT ID: NCT06325111
Last Updated: 2024-03-22
Study Results
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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RECRUITING
800 participants
OBSERVATIONAL
2023-05-29
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Patients with T1D and optimal glycaemic control
Optimal glycaemic control will be defined as HbA1c values \<7%
Determinants of T1D glycaemic control
DNA genotyping, microbiome, DNA methylation and microRNAs analysis
Patients with T1D and poor glycaemic control
Poor glycemic control will be defined as HbA1c value ≥7%
Determinants of T1D glycaemic control
DNA genotyping, microbiome, DNA methylation and microRNAs analysis
Interventions
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Determinants of T1D glycaemic control
DNA genotyping, microbiome, DNA methylation and microRNAs analysis
Eligibility Criteria
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Inclusion Criteria
* Age from 6 to 20 years old
* At least 5 years of duration of disease
Exclusion Criteria
* 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)
6 Years
20 Years
ALL
No
Sponsors
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IRCCS Burlo Garofolo
OTHER
Responsible Party
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Locations
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Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC 06/2023
Identifier Type: -
Identifier Source: org_study_id
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