跳至主要内容
临床试验/NCT05525416
NCT05525416已完成不适用

Sex Differences in Sympathetic Vascular Reactivity at High Altitude

University of Alberta2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年7月28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
17
试验地点
2
主要终点
Change in systolic, diastolic, and mean arterial 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 and millions of others travel to high altitude every year for work or pleasure. At high altitude participants are exposed to a lower than normal level of oxygen, also known as hypoxia. This causes stress to the human body, which will adapt in order to maintain adequate oxygen delivery to its tissues. One of these adaptations is an increase in activity of participants' sympathetic nervous system ("fight or flight" response). Sympathetic nerve activity affects the size of participants' blood vessels, which in turn will affect blood pressure. Men and women regulate their blood pressure in different ways; for example, women tend to have lower blood pressure and sympathetic nerve activity than men. Women also appear to have less constriction of their blood vessels in response to stress. This may be in part because estrogen causes blood vessels to dilate. It may also be due to differences in the receptors which are activated by the sympathetic nervous system. These receptors are called alpha and beta receptors and respond to sympathetic nerve activity in opposite directions. Women represent 50% of the population living at and travelling to high altitude, therefore, it is important to understand the differences in how men and women respond to low oxygen.

The main purpose of this study is to examine the differences between men and women in the sympathetic nervous system control of blood vessels during exposure to low oxygen. To study this question, the investigators will test how blood vessels respond to stressors in both men and women. Participants will be recruited at the Canadian sites, and the investigators will test them while they breathe low oxygen for a short amount of time at low altitude. The investigators 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.

入排标准

年龄范围
18 Years 至 45 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)
  • Participants who are current daily smokers
  • Those with a known allergy to sulfites
  • Participants taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants or other medications that have contraindications with the study drugs
  • Participants who are still within the washout period from participating in other studies involving drugs.

研究组 & 干预措施

Low Altitude

Experimental

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

干预措施: Rhythmic Handgrip (Other)

Low Altitude

Experimental

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

干预措施: Sodium Nitroprusside (Drug)

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: Norepinephrine (Drug)

Low Altitude

Experimental

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

干预措施: Isometric Handgrip and Post-Exercise Circulatory Occlusion (Other)

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: Propranolol Hydrochloride (Drug)

Low Altitude

Experimental

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

干预措施: Phentolamine Mesylate (Drug)

High Altitude

Experimental

Participants will be assessed on a high-altitude expedition at an elevation of 3,800m.

干预措施: Sodium Nitroprusside (Drug)

High Altitude

Experimental

Participants will be assessed on a high-altitude expedition at an elevation of 3,800m.

干预措施: Phenylephrine Hydrochloride (Drug)

High Altitude

Experimental

Participants will be assessed on a high-altitude expedition at an elevation of 3,800m.

干预措施: Norepinephrine (Drug)

High Altitude

Experimental

Participants will be assessed on a high-altitude expedition at an elevation of 3,800m.

干预措施: Isometric Handgrip and Post-Exercise Circulatory Occlusion (Other)

High Altitude

Experimental

Participants will be assessed on a high-altitude expedition at an elevation of 3,800m.

干预措施: Rhythmic Handgrip (Other)

High Altitude

Experimental

Participants will be assessed on a high-altitude expedition at an elevation of 3,800m.

干预措施: Cold Pressor Test (Other)

High Altitude

Experimental

Participants will be assessed on a high-altitude expedition at an elevation of 3,800m.

干预措施: Propranolol Hydrochloride (Drug)

High Altitude

Experimental

Participants will be assessed on a high-altitude expedition at an elevation of 3,800m.

干预措施: Phentolamine Mesylate (Drug)

结局指标

主要结局

Change in systolic, diastolic, and mean arterial blood pressure

时间窗: 3 minutes

modified oxford

Propranolol

时间窗: 2 hours

changes in vascular conductance

Change in arterial blood flow

时间窗: 1 hour 30 minutes

phenylephrine and norepinephrine sensitivity

Cold pressor test

时间窗: 3 minutes

sympathetic reactivity

Change in vascular conductance

时间窗: 20 minutes

exercise and metaboreflex reactivity

Phentolamine

时间窗: 1 hour

changes in vascular conductance

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)

Loading locations...

相似试验

Sex Differences in Sympathetic Vascular Reactivity... | 临床试验