Hopital Femme Mère Enfant - Groupement Hospitalier Est
Bron, 69677, France
NCT Number: NCT03912012
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 it's 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 ED's and GHF's 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.
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Notify Me10 year–18 year
All sexes
Interventional
Not applicable
Bron, 69677, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous injection of Iohexol (Omnipaque 300mg) with blood sampling at 0, 120, 180 and 240 minutes (during Day 1.
endothelial function evaluated following a protocol of iontophoresis of acetylcholine (during Day 1).
carotid ultrasound (during Day 1)
37 mL of blood sample will be performed at Day 1
The urinary collection will be done during the Day 1, on the first morning urination
assessment of the Body Mass Index by HR-pQCT (during the Day 1)
assessment of bone parameters by DXA (during the Day 1)
Time frame: Day 1
assessed through Iohexol renal clearance measurement
Time frame: Day 1
Endothelial function will be evaluated by the microcirculation assessment through Laser Doppler associated to iontophoresis of acetylcholine.
Time frame: Day 1
The intima media thickness will be performed by Echo Doppler of both right and left common carotid
Time frame: Day 1
arterial blood pressure measurement
Time frame: Day 1
Bone mass will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
Time frame: Day 1
bone density will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
Time frame: Day 1
quantization of bone mineral content will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
Time frame: Day 1
Volumetric compartmental density will be performed by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) on radius and tibia (Right tibia and non-dominant arm radius). (Unless there is a history of fracture for one of those bones, in which case the opposite side will be studied instead.)
Time frame: Day 1
trabecular microarchitecture will be performed by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) on radius and tibia (Right tibia and non-dominant arm radius). (Unless there is a history of fracture for one of those bones, in which case the opposite side will be studied instead.)
Hospices Civils de Lyon
Other
Endothelial Dysfunction Could be an Early Biomarker of Renal Impairment in Children and Adolescent With Type 1 Diabetes. Pilot Study DiaDEP
Acronym: DiaDEP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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