Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03912012
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2019-04-09
Brief Title:
Pilot Study DiaDEP
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Endothelial Dysfunction Could be an Early Biomarker of Renal Impairment in Children and Adolescent With Type 1 Diabetes Pilot Study DiaDEP
Status:
COMPLETED
Status Verified Date:
2024-02
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:
DiaDEP
Brief Summary:
With an increased incidence of pediatric type 1 diabetes T1D and a decrease in age at diagnosis children are exposed to complications such as renal impairment at a very young age
The current biomarker used to diagnose renal impairment is microalbuminuria but its a late marker Early screening is a major issue to reduce T1D consequences
Early glomerular hyperfiltration GHF could participate in the development and progression of nephropathy Hyperfiltration has also been associated with a systemic endothelial dysfunction and with changes in arterial stiffness suggesting at least to a certain extent a state of generalized vascular dysfunction
Diabetes is responsible for very early neurovascular dysfunctions detectable with techniques to evaluate cutaneous neurovascular interaction Those should help bringing to light very early microcirculation impairment particularly precocious endothelial dysfunction ED
No study about correlation between GHF and ED is currently available The hypothesis assessed is those of a strong correlation between ED and GHF in children and adolescent with a story of T1D for at least 10 years
This pilot study should allow assessing EDs and GHFs proportions in our population in order to conduct a larger study to prove in a prospective way the prognostic value of ED in the apparition of nephropathy taking into count other factors such as diabetes duration or stability
This measure could be included in the global evaluation of microangiopathy risk in children and then take action to prevent negative outcomes
The second aspect of this study is the assessment of other functions and metabolisms possibly impaired in T1D osseous microarchitecture vitamin D status and precocious evaluation of macro angiopathy through intima media thickness measurement
Long term diabetes in children is associated with shorter and leaner bones despite a correct mineralization a reduced bone density and a fracture risk increased six fold Bone status in the population will be evaluated through the study of bones microarchitecture via HR-pQCT High Resolution peripheral Quantitative Computed Tomography on both tibia and radius dual-energy X-ray absorptiometry DXA and bone turn over biochemical markers
Results on bone microarchitecture in a preexisting cohort of healthy children and adolescents will be used to compare results
The current biomarker used to diagnose renal impairment is microalbuminuria but its a late marker Early screening is a major issue to reduce T1D consequences
Early glomerular hyperfiltration GHF could participate in the development and progression of nephropathy Hyperfiltration has also been associated with a systemic endothelial dysfunction and with changes in arterial stiffness suggesting at least to a certain extent a state of generalized vascular dysfunction
Diabetes is responsible for very early neurovascular dysfunctions detectable with techniques to evaluate cutaneous neurovascular interaction Those should help bringing to light very early microcirculation impairment particularly precocious endothelial dysfunction ED
No study about correlation between GHF and ED is currently available The hypothesis assessed is those of a strong correlation between ED and GHF in children and adolescent with a story of T1D for at least 10 years
This pilot study should allow assessing EDs and GHFs proportions in our population in order to conduct a larger study to prove in a prospective way the prognostic value of ED in the apparition of nephropathy taking into count other factors such as diabetes duration or stability
This measure could be included in the global evaluation of microangiopathy risk in children and then take action to prevent negative outcomes
The second aspect of this study is the assessment of other functions and metabolisms possibly impaired in T1D osseous microarchitecture vitamin D status and precocious evaluation of macro angiopathy through intima media thickness measurement
Long term diabetes in children is associated with shorter and leaner bones despite a correct mineralization a reduced bone density and a fracture risk increased six fold Bone status in the population will be evaluated through the study of bones microarchitecture via HR-pQCT High Resolution peripheral Quantitative Computed Tomography on both tibia and radius dual-energy X-ray absorptiometry DXA and bone turn over biochemical markers
Results on bone microarchitecture in a preexisting cohort of healthy children and adolescents will be used to compare results
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