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临床试验/NCT03404011
NCT03404011已完成不适用

Acute Effects of Propylene Glycol/Glycerol Intake on Cardiorespiratory Blood Parameters

Université Libre de Bruxelles2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年1月15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
入组人数
24
试验地点
2
主要终点
Cardiorespiratory biological variables

研究概览

简要总结

The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters.

详细描述

Background : Propylene glycol/glycerol intake is increasingly popular. Acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters is unknown. The investigators postulate that intake of propylene glycol and glycerol could modifiy cardiorespiratory blood parameters.

Aims of this study : to test the following hypotheses :

  1. Acute intake of propylene glycol and glycerol modifies cardiorespiratory blood parameters.

To test this hypothesis, we will perform blood samples before and after intake of propylene glycol and glycerol. Participants will be tobacco smoker between 18 and 70 years old, with multiple cardiovascular risk factors, and who will undergo a cardiac catherization. After the cardiac catherization, the catheter will be used to perform serial blood samples.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject undergoing cardiac catherization
  • Subject must be an active tobacco smoker

排除标准

  • Symptoms of infection or inflammation
  • Acute disease including heart rhythm disorder, acute coronary syndrome or decompensation of a chronic disease (heart failure, COPD,...)
  • Unexpected and undesirable effects during the cardiac catherization procedure
  • Respiratory failure requiring supplementary oxygen

研究组 & 干预措施

Propylene glycol and Glycerol intake

Experimental

One gram intake of a Propylene glycol/Glycerol mix (50:50)

干预措施: Propylene glycol and Glycerol intake (Other)

Mimicking intake

Placebo Comparator

Mimicking Propylene glycol/Glycerol intake with the device turns off

干预措施: Mimicking intake (Device)

结局指标

主要结局

Cardiorespiratory biological variables

时间窗: 5 minutes

Blood sample

次要结局

  • Cardiorespiratory biological variables(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Chaumont

MD, Cardiology Fellow

Université Libre de Bruxelles

研究点 (2)

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