Pilot Study DiaDEP
Condition: Diabetes Mellitus, Type 1; Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    


Intervention name(s): Iohexol renal clearance measurement; microcirculation assessment through Laser Doppler associated to iontophoresis.; Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement; Blood sampling; Urine sampling; High-resolution peripheral quantitative computed tomography (HR-pQCT); Dual-energy X-ray (DXA)
Intervention type(s): Drug; Device; Device; Biological; Biological; Device; Radiation
Intervention description(s): 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)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes mellitus type 1; Type 1 diabetes; diabetes; pediatrics; Glomerular hyperfiltration; endothelial dysfunction; children; adolescent