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临床试验/NCT05001048
NCT05001048已完成不适用

Sex Differences in Sympathetic Activity and Vascular Reactivity During Acute and Chronic Hypoxia.

University of Alberta2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年8月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Change in blood pressure

研究概览

简要总结

This study aims to investigate sex differences in blood pressure control associated with exposure to acute hypoxia (low oxygen), and short term acclimatization to hypoxia at high altitude.

详细描述

About 200 million people worldwide live at high altitudes. Millions of others travel to high altitude every year for work or travel. The low oxygen (or hypoxia) experienced at high altitudes causes considerable physiological stress, and the body adapts in order to maintain adequate oxygen delivery to its tissues. One of these adaptations is an increase in the activity of the sympathetic nervous system. This system is responsible for the "fight or flight" response. Sympathetic activity regulates the size of the blood vessels, which will affect blood pressure. Previous studies suggest that males and females regulate their blood pressure in different ways. Females tend to have lower resting sympathetic activity, and less vasoconstriction in response to stressors than males. Blood pressure changes are also influenced by levels of sex hormones; for example, estrogen may cause opposing vasodilation. Therefore, it is important to understand the differences in how males and females respond to low oxygen.

The main purpose of this study is to examine the differences between males and females in control of blood vessels during exposure to low oxygen. To study this question, we will test vasoreactivity to set physiological stressors in both males and females. Participants will be recruited at the Canadian sites, and we will test them while they breathe low oxygen for a short amount of time at low altitude. We will also perform assessments on the same participants during a two week stay at high altitude at White Mountain, CA, which is at an altitude of 3,800m. These data will have implications in the basic understanding of differences between male and female physiology. Specifically, to males and females living or travelling to high altitude.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

盲法说明

Due to the study design, masking is not possible. The time points and dosages of the study drug will be known to the participant. Further, due to the wash-out time of the acute hypoxia/hyperoxia interventions, these will always be completed second to the interventions breathing room air.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between ages of 18-50
  • No medical history of cardiovascular, respiratory, nervous system, or metabolic disease
  • Females must be pre-menopausal

排除标准

  • Any known cardiovascular, respiratory, nervous system, or metabolic disease (however, participants with controlled arterial hypertension will not be excluded)
  • Having travelled above 2,000m within 1 month of testing at low and high altitude
  • Females who are pregnant, confirmed by a pregnancy test
  • Females who are post-menopausal
  • Participants that are classified as obese (body mass index > 30kg⋅m²)
  • Have a history of smoking regularly in the last 6 months (but nicotine substitutes (patch, gum) not an exclusion criteria)
  • Those with a known allergy to sulfites
  • Participants taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants

研究组 & 干预措施

Low Altitude

Experimental

Participants will be assessed at an altitude of <1050m.

干预措施: Phenylephrine Hydrochloride (Drug)

Low Altitude

Experimental

Participants will be assessed at an altitude of <1050m.

干预措施: Cold Pressor Test (Other)

Low Altitude

Experimental

Participants will be assessed at an altitude of <1050m.

干预措施: Isocapnic Acute Hypoxia (Other)

Early Acclimatization to High Altitude

Experimental

Participants will be assessed on day 2 or 3 of a high-altitude expedition at 3,800m.

干预措施: Phenylephrine Hydrochloride (Drug)

Early Acclimatization to High Altitude

Experimental

Participants will be assessed on day 2 or 3 of a high-altitude expedition at 3,800m.

干预措施: Cold Pressor Test (Other)

Early Acclimatization to High Altitude

Experimental

Participants will be assessed on day 2 or 3 of a high-altitude expedition at 3,800m.

干预措施: Hyperoxia (Other)

Late Acclimatization to High Altitude

Experimental

Participants will be assessed on day 9 or 10 of a high-altitude expedition at 3,800m.

干预措施: Phenylephrine Hydrochloride (Drug)

Late Acclimatization to High Altitude

Experimental

Participants will be assessed on day 9 or 10 of a high-altitude expedition at 3,800m.

干预措施: Cold Pressor Test (Other)

Late Acclimatization to High Altitude

Experimental

Participants will be assessed on day 9 or 10 of a high-altitude expedition at 3,800m.

干预措施: Hyperoxia (Other)

结局指标

主要结局

Change in blood pressure

时间窗: 18 minutes

Phenylephrine sensitivity

Change in arterial blood flow

时间窗: 18 minutes

Phenylephrine sensitivity

Cold pressor test reactivity

时间窗: 4 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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