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Clinical Trials/NCT05001048
NCT05001048
Completed
Not Applicable

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

University of Alberta2 sites in 1 country14 target enrollmentAugust 4, 2019

Overview

Phase
Not Applicable
Intervention
Phenylephrine Hydrochloride
Conditions
Vasodilation
Sponsor
University of Alberta
Enrollment
14
Locations
2
Primary Endpoint
Change in blood pressure
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 4, 2019
End Date
September 9, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Low Altitude

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

Intervention: Phenylephrine Hydrochloride

Low Altitude

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

Intervention: Cold Pressor Test

Low Altitude

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

Intervention: Isocapnic Acute Hypoxia

Early Acclimatization to High Altitude

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

Intervention: Phenylephrine Hydrochloride

Early Acclimatization to High Altitude

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

Intervention: Cold Pressor Test

Early Acclimatization to High Altitude

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

Intervention: Hyperoxia

Late Acclimatization to High Altitude

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

Intervention: Phenylephrine Hydrochloride

Late Acclimatization to High Altitude

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

Intervention: Cold Pressor Test

Late Acclimatization to High Altitude

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

Intervention: Hyperoxia

Outcomes

Primary Outcomes

Change in blood pressure

Time Frame: 18 minutes

Phenylephrine sensitivity

Change in arterial blood flow

Time Frame: 18 minutes

Phenylephrine sensitivity

Cold pressor test reactivity

Time Frame: 4 minutes

Study Sites (2)

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