Pilot Study DiaDEP (DiaDEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03912012|
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : July 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Type1diabetes||Drug: Iohexol renal clearance measurement Device: microcirculation assessment through Laser Doppler associated to iontophoresis. Device: Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement Biological: Blood sampling Biological: Urine sampling Device: High-resolution peripheral quantitative computed tomography (HR-pQCT) Radiation: Dual-energy X-ray (DXA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endothelial Dysfunction Could be an Early Biomarker of Renal Impairment in Children and Adolescent With Type 1 Diabetes. Pilot Study DiaDEP|
|Actual Study Start Date :||July 9, 2019|
|Estimated Primary Completion Date :||January 9, 2021|
|Estimated Study Completion Date :||January 9, 2021|
Children and adolescent with a history of type 1 diabetes
Children and adolescent from 10 to 18 years old, with a history of type 1 diabetes for at least 10 years. Glomerular hyper filtration and endothelial dysfunction will be evaluate.
Drug: Iohexol renal clearance measurement
intravenous injection of Iohexol (Omnipaque 300mg) with blood sampling at 0, 120, 180 and 240 minutes (during Day 1.
Device: microcirculation assessment through Laser Doppler associated to iontophoresis.
endothelial function evaluated following a protocol of iontophoresis of acetylcholine (during Day 1).
Device: Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement
carotid ultrasound (during Day 1)
Biological: Blood sampling
37 mL of blood sample will be performed at Day 1
Biological: Urine sampling
The urinary collection will be done during the Day 1, on the first morning urination
Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)
assessment of the Body Mass Index by HR-pQCT (during the Day 1)
Radiation: Dual-energy X-ray (DXA)
assessment of bone parameters by DXA (during the Day 1)
- Glomerular hyper filtration (Glomerular filtration > 135 mL/min/1,73 m2) [ Time Frame: Day 1 ]assessed through Iohexol renal clearance measurement
- Endothelial function in the forearm. [ Time Frame: Day 1 ]Endothelial function will be evaluated by the microcirculation assessment through Laser Doppler associated to iontophoresis of acetylcholine.
- Intima media thickness [ Time Frame: Day 1 ]The intima media thickness will be performed by Echo Doppler of both right and left common carotid
- arterial blood pressure [ Time Frame: Day 1 ]arterial blood pressure measurement
- Bone mass [ Time Frame: Day 1 ]Bone mass will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
- bone density [ Time Frame: Day 1 ]bone density will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
- quantization of bone mineral content [ 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.
- Volumetric compartmental density [ 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.)
- trabecular microarchitecture [ 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.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912012
|Contact: Aurelie Portefaix, MD, PhD||04 72 35 79 99 ext +email@example.com|
|Contact: Meriem EL JANI||04 27 85 77 25 ext +firstname.lastname@example.org|
|Hopital Femme Mère Enfant - Groupement Hospitalier Est||Recruiting|
|Bron, France, 69677|
|Contact: Aurélie Portefaix, MD, PhD 04.72.35.79.99 ext +33 email@example.com|
|Contact: Meriem El-Jani 04 27 85 77 25 ext +33 firstname.lastname@example.org|
|Principal Investigator: Aurélie Portefaix, MD, PhD|