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临床试验/NCT03506711
NCT03506711已完成不适用

Non-invasive Assessment of Endothelial Function in Children and Adolescents With Type 1 Diabetes Mellitus Using Isometric Handgrip Exercise -MRI: A Feasibility Study

University of Lausanne Hospitals1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Change in coronary cross sectional area (mm2)

研究概览

简要总结

This project aims to assess coronary vessel response to isometric handgrip exercise (IHE) during magnetic resonance imaging (MRI) in children with T1D children and healthy controls. The investigators will compare the groups in terms of surrogate markers of intima media alteration and arterial stiffness, i.e. carotid intima media thickness (CIMT) and aortic pulse wave velocity (PWV).

详细描述

Background Type 1 diabetes mellitus (T1D) in children and adolescents is associated with significant cardiovascular morbidity and mortality. Early detection of vascular dysfunction is key to management yet assessment is invasive - which is particularly challenging when considering pediatric patient populations. Recently, a novel approach using isometric handgrip exercise (IHE) during magnetic resonance imaging (MRI) has been developed to evaluate coronary endothelial function in adults.

This project aims to assess coronary vessel response to IHE using MRI in children with T1D children and healthy controls. In addition, the investigators will compare the groups in terms of surrogate markers of intima media alteration and arterial stiffness, i.e. carotid intima media thickness (CIMT) and aortic pulse wave velocity (PWV).

Community-dwelling healthy volunteers (<18 years-old) and children with type 1 diabetes mellitus (disease duration ≥ 5 years) are recruited. IHE-MRI studies are conducted and measurements are recorded at rest (baseline) and under stress (IHE at 30% maximal effort). Carotic Ultrasound and Sphygmocor CPV System are used to assess CIMT and PWV respectively. Student's T-tests are used to compare results between groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Type 1 Diabetes mellitus or
  • •Healthy community-dwelling children on no medications

排除标准

  • •obesity (BMI >97th percentile)
  • •systolic or diastolic hypertension (>90th percentile)
  • •inflammatory process.

研究组 & 干预措施

T1DM Children and adolescents

Active Comparator

Children and adolescents with Type 1 Diabetes Mellitus

干预措施: Isometric Handgrip Exercise during magnetic resonance imaging (Diagnostic Test)

Healthy Children and adolescents

Active Comparator

Healthy community-dwelling children on no medication

干预措施: Isometric Handgrip Exercise during magnetic resonance imaging (Diagnostic Test)

结局指标

主要结局

Change in coronary cross sectional area (mm2)

时间窗: Baseline and up to 3 years

Change from rest to that during isometric handgrip exercise (IHE).

次要结局

未报告次要终点

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Hauschild

Head of clinical pediatric endocrinology diabetology unit

University of Lausanne Hospitals

研究点 (1)

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