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临床试验/NCT03226587
NCT03226587已完成不适用

Acute Effects of Whole Body Blue Light Exposure on Blood Pressure, Endothelial Function and Vascular Stiffness

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年8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
20
试验地点
2
主要终点
Change of peripheral blood pressure

研究概览

简要总结

Ultraviolet light exposure was shown to be able to release nitric oxide from the skin into the blood stream and lead to an acute decrease in blood pressure and increase in vascular function. Additionally, preliminary work indicates that UV free blue light also releases nitric oxide in the skin mediating similar effects as seen with ultraviolet light A(UVA). It is the goal of the present experimental study to investigate the hemodynamic effects of whole body blue light exposure including blood pressure, endothelial function and vascular stiffness. Therefore, healthy volunteers will be exposed to 30 minutes whole body blue light (453 nm wavelength) and the change in blood pressure and endothelial function (Flow mediated dilation (FMD)), heart rate, forearm-blood flow, forearm vascular resistance central blood pressure and vascular stiffness ( pulse wave analysis by sphygmocor) will be measured.

In this randomized controlled cross-over study, 20 healthy subjects aged 30 to 60 years will participate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy, male subjects
  • age between 30 and 60 years
  • signed patient informed consent

排除标准

  • diabetes mellitus
  • acute inflammation (CRP >0.5mg/dl)
  • cardiac arrythmia
  • active cancer
  • renal failure
  • heart failure (NYHA II-IV)
  • arterial hypotension (systolic pressure <100 mmHg)
  • treatment with antihypertensive drugs
  • dermatosis of the eyelid
  • porphyria or hypersensitivity to porphyrins
  • congenital or aсquired immune deficiency
  • genetic conditions that cause an increased sensitivity to light or an increased risk to dermatological cancer (such as xeroderma pigmentosum, cockayne syndrome, bloom syndrome)
  • previous intake or use of photosensitizing drugs, food or cosmetics (e.g. psychiatric medication, antibiotics, cardiovascular drugs, hormone, Hypericum, Bergamot orange) or use of perfumes

研究组 & 干预措施

Blue light

Experimental

Each subject will be undergo a whole body exposure to blue light (453 nm wavelength) for 30 minutes.

干预措施: Blue light (Procedure)

Control exposure

Placebo Comparator

Each participant will also undergo a control examination, where the body will be covered with a light tight foil during blue light exposure for 30 minutes.

干预措施: control exposure (Procedure)

结局指标

主要结局

Change of peripheral blood pressure

时间窗: baseline, during 30 min exposure and 2 hours thereafter

Change of peripheral blood pressure as measured before, during and up to 2 hours after 30 min blue light as compared to control

次要结局

  • Change from baseline forearm blood flow(baseline, during 30 min exposure and 2 hours thereafter)
  • Change from baseline NO-species(baseline, during 30 min exposure and 2 hours thereafter)
  • Change from baseline heart rate(baseline, during 30 min exposure and 2 hours thereafter)
  • Change from baseline central blood pressure(baseline, during 30 min exposure and 2 hours thereafter)
  • Change from baseline forearm vascular resistance(baseline, during 30 min exposure and 2 hours thereafter)
  • Change from baseline Endorphins(baseline, during 30 min exposure and 2 hours thereafter)
  • Change in endothelial function(baseline, during 30 min exposure and 2 hours thereafter)
  • Change from baseline vascular stiffness(baseline, during 30 min exposure and 2 hours thereafter)
  • Change from baseline Cortisol(baseline, during 30 min exposure and 2 hours thereafter)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

PD Dr. med. Christian Heiß

Heinrich-Heine University, Duesseldorf

研究点 (2)

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