Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325111
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-15
Brief Title:
Determinants of Glycaemic Control in Children With Type 1 Diabetes
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Exploring Genetic Epigenetic and Environmental Determinants of Glycaemic Control in Children and Young Individuals With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 hyperglycaemias 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
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 hyperglycaemias 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None