Endothelial Dysfunction Could be an Early Biomarker of Renal Impairment in Children and Adolescent With Type 1 Diabetes. Pilot Study DiaDEP

Hospices Civils de Lyon1 个研究点分布在 1 个国家目标入组 23 人开始时间: 2019年7月9日最近更新: 2024年2月28日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Hospices Civils de Lyon
入组人数: 23
试验地点: 1
主要终点: Glomerular hyper filtration (Glomerular filtration > 135 mL/min/1,73 m2)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

年龄范围: 10 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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
•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;