Pilot Study DiaDEP

Not Applicable

Completed

Conditions: Type1diabetes
Diabetes Mellitus, Type 1

Interventions: 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)

Registration Number: NCT03912012

Lead Sponsor: Hospices Civils de Lyon

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

Inclusion Criteria

Aged ≥ 10 et < 18 years old
Type 1 diabetes diagnosed more than 10 years previously.
Written informed consent signed by both parents or legal representatives, child or adolescent's agreement.
Health cover

Exclusion Criteria

Associated pathology with a potential impact on cutaneous microcirculation or renal function.
Aspirin or other non-steroid anti-inflammatory treatment with potential impact on endothelial function in the 3 weeks preceding the visit.
Examination with injection of contrast agent during the last 48 hours
Smoking
Ongoing pregnancy or breast feeding
Hypersensitivity to acetylcholine
Contraindication to Iohexol
Ongoing treatment with growth hormone, non-inhaled corticosteroids or anti-calcineurins;
History of treatment with oral corticosteroids (not inhaled) more than 3 successive months regardless of seniority;
Paracetamol treatment less than a week old;

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children and adolescent with a history of type 1 diabetes	Iohexol renal clearance measurement	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.
Children and adolescent with a history of type 1 diabetes	Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement	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.
Children and adolescent with a history of type 1 diabetes	microcirculation assessment through Laser Doppler associated to iontophoresis.	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.
Children and adolescent with a history of type 1 diabetes	Blood sampling	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.
Children and adolescent with a history of type 1 diabetes	Urine sampling	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.
Children and adolescent with a history of type 1 diabetes	Dual-energy X-ray (DXA)	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.
Children and adolescent with a history of type 1 diabetes	High-resolution peripheral quantitative computed tomography (HR-pQCT)	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.

Primary Outcome Measures

Name	Time	Method
Glomerular hyper filtration (Glomerular filtration > 135 mL/min/1,73 m2)	Day 1	assessed through Iohexol renal clearance measurement

Secondary Outcome Measures

Name	Time	Method
Endothelial function in the forearm.	Day 1	Endothelial function will be evaluated by the microcirculation assessment through Laser Doppler associated to iontophoresis of acetylcholine.
Intima media thickness	Day 1	The intima media thickness will be performed by Echo Doppler of both right and left common carotid
Volumetric compartmental density	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.)
quantization of bone mineral content	Day 1	quantization of bone mineral content will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
trabecular microarchitecture	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.)
arterial blood pressure	Day 1	arterial blood pressure measurement
Bone mass	Day 1	Bone mass will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
bone density	Day 1	bone density will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.

Trial Locations

Locations (1): Hopital Femme Mère Enfant - Groupement Hospitalier Est
🇫🇷
Bron, France

Pilot Study DiaDEP

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