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临床试验/NCT02001753
NCT02001753已完成4 期

Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes

Xiang Guang-da1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2013年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes

研究概览

简要总结

Magnetic resonance (MR) imaging is a widely used and well-established noninvasive medical diagnostic imaging tool. By using a static and a gradient magnetic field in combination with a radiofrequency field (RF), MR provides excellent contrast among different tissues of the body. Although long-term effects on human health from exposure to strong static magnetic fields seem unlikely, acute effects such as vertigo, nausea, change in blood pressure, reversible arrhythmia, and neurobehavioural effects have been documented from occupational exposition to 1.5 T. Cardiac MR (CMR) imaging requires some of the strongest and fastest switching electromagnetic gradients available in MR exposing the patients to the highest administered energy levels accepted by the controlling authorities. Studies focusing on experimental teratogenic or carcinogenic effects of MR revealed conflicting results. Since CMR is emerging as one of the fastest growing new fields of broad MR application, it is of particular concern that a recent in vitro study with CMR sequences has reported on CMR-induced DNA damages in white blood cells up to 24 h after exposure to 1.5 T CMR. Therefore, we hypothesized that CMR can induce the damage of endothelium and endothelial progenitor cells in type 2 diabetes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 30 to 65 years old
  • Type 2 diabetes

排除标准

  • Renal and liver function dysfunction
  • Heart failure
  • Malignancy
  • Patients with contraindications to cardiac magnetic resonance (CMR)
  • Patients with clinical detectable angiopathy

结局指标

主要结局

Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes

时间窗: 3 days

The endothelium-dependent arterial dilation was measured at baseline, 1day, 2 day, 3 day after CMR.

次要结局

  • Changes of endothelial progenitor cells before and after CMR in peripheral blood(3 days)

研究者

发起方
Xiang Guang-da
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiang Guang-da

Director of Endocrinology, Wuhan General Hospital

Wuhan General Hospital of Guangzhou Military Command

研究点 (1)

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