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临床试验/NCT04819204
NCT04819204Unknown不适用

Exploring the Role of Testosterone on Neurovascular Control in Humans

Western University, Canada1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Muscle sympathetic nerve activity

研究概览

简要总结

The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in men.

详细描述

Sex hormones play a pivotal role in neurovascular function in humans. In recent years, great strides have been made in elucidating the roles of estrogen and progesterone on autonomic and vascular control in women; however, very little is known about the impact of testosterone in men. Given that low testosterone levels are associated with an increased risk of cardiovascular disease, reduced exercise capacity and vascular dysfunction, it is evident that testosterone plays a pivotal role in autonomic and vascular function in men. Our current understanding of testosterone's effects on neurovascular control are confounded by numerous factors that independently alter autonomic and vascular function such as aging and chronic disease (e.g. cardiovascular disease, metabolic disease). The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in young men to better isolate the effects of testosterone from the aforementioned confounding factors. The outcomes of these studies will provide novel information regarding the role of male sex hormones in autonomic and vascular control, and further our understanding of the influence of sex hormones on human physiology.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Moderately active
  • Free of chronic disease

排除标准

  • congenital or acquired hypogonadism
  • drug/alcohol dependence
  • hypertension
  • current smoker
  • current opioid or cannabis user
  • inability to provide written consent
  • parkinson's disease
  • cardiovascular disease
  • testosterone use within the last year

研究组 & 干预措施

GnRH antagonist alone

Experimental

Intervention: Cetrorelix acetate (Cetrotide)

干预措施: Cetrorelix Acetate (Drug)

GnRH antagonist + Testosterone add-back

Experimental

Intervention: Cetrorelix acetate (Cetrotide) + Testosterone gel (Androgel)

干预措施: Cetrorelix Acetate (Drug)

GnRH antagonist + Testosterone add-back

Experimental

Intervention: Cetrorelix acetate (Cetrotide) + Testosterone gel (Androgel)

干预措施: Testosterone gel (Drug)

结局指标

主要结局

Muscle sympathetic nerve activity

时间窗: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Multi-unit postganglionic muscle sympathetic nerve activity (MSNA) will be measured by inserting a unipolar tungsten microelectrode into the peroneal nerve near the fibular head of the leg. Neural signals will be amplified, filtered (bandwidth, 700-2,000 Hz), rectified, and integrated (time constant, 0.1 s) to obtain mean voltage neurograms. MSNA will be measured during both trials to evaluate the effect of testosterone on sympathetic activity directed toward the musculature.

Endothelial function

时间窗: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Brachial artery flow-mediated dilation (FMD). Brachial artery FMD measures will be performed non-invasively via Doppler ultrasound.

Forearm blood flow

时间窗: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Forearm blood flow will be measured using Doppler ultrasound at baseline and during stress (e.g. exercise)

次要结局

  • Skeletal muscle microvascular blood flow(After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Shoemaker

Principal Investigator

Western University, Canada

研究点 (1)

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