Mirabegron and Physiological Function in Cold Environments

Mirabegron and Physiological Function in Cold Environments

赞助商

首席赞助商: Indiana University

合作者: Office of Naval Research (ONR)

资源 Indiana University
简要总结

Many Navy diving operations are performed in cold water. Despite technical advances to improve thermal protection for cold water diving, these applications are cumbersome and do not provide complete thermal protection as thermal discomfort is subjectively reported by many Navy divers. Brown adipose tissue is highly thermogenic in humans. Therefore, activation of brown adipose tissue might improve cold water tolerance and lower thermal discomfort during cold water diving operations. Mirabegron is a beta-3-adrenergic receptor agonist that is used to treat overactive bladder. Beta-3-adrenergic receptors are located on the urinary bladder, gallbladder and brown adipose tissue. Recent evidence has demonstrated that acute mirabegron administration increases thermogenesis for ~3 hours in humans. However, it is currently not known which dose of mirabegron can increase thermogenesis for longer durations. It is also not known if mirabegron administration can improve cold water tolerance and thermal discomfort during cold water immersion. Finally, it is not known if mirabegron can increase thermogenesis during sympathetic stimulation. This project will fill these knowledge gaps by addressing these specific aims: 1) determine which dose of mirabegron administration will increase thermogenesis during 6 hours of a mild cold stress challenge, 2) determine if acute mirabegron administration will delay the fall in core temperature and the onset of shivering during a progressive cold-water immersion challenge, and 3) compare the dose of isoproterenol required to evoke a thermogenic response equal to a 15% increase above rest, following ingestion of either mirabegron or a placebo. In addition to filling these knowledge gaps, the activation of brown adipose tissue by mirabegron might be influenced by the gut microbiome. Therefore, the association between the gut microbiome and mirabegron metabolism will be explored. Collectively, these studies will show if mirabegron is a potential ergogenic aid that can be used to improve cold water tolerance in Navy divers which will ultimately improve the likelihood of successful missions.

总体状况 Not yet recruiting
开始日期 May 2021
完成日期 May 2023
主要完成日期 May 2023
Phase 1/Phase 2
研究类型 Interventional
主要结果
测量 大体时间
Resting Energy Expenditure Baseline
Resting Energy Expenditure 30 minutes
Resting Energy Expenditure 60 minutes
Resting Energy Expenditure 90 minutes
Resting Energy Expenditure 120 minutes
Resting Energy Expenditure 150 minutes
Resting Energy Expenditure 180 minutes
Resting Energy Expenditure 210 minutes
Resting Energy Expenditure 240 minutes
Resting Energy Expenditure 270 minutes
Resting Energy Expenditure 300 minutes
Resting Energy Expenditure 330 minutes
Resting Energy Expenditure 360 minutes
次要结果
测量 大体时间
Core Body Temperature Baseline
Core Body Temperature 1 hour
Core Body Temperature 2 hour
Core Body Temperature 3 hour
Core Body Temperature 4 hour
Core Body Temperature 5 hour
Core Body Temperature 6 hour
Brown adipose tissue activation Baseline
Brown adipose tissue activation 1 hour
Brown adipose tissue activation 2 hour
Brown adipose tissue activation 3 hour
Brown adipose tissue activation 4 hour
Brown adipose tissue activation 5 hour
Brown adipose tissue activation 6 hour
注册 30
健康)状况
介入

干预类型: Drug

干预名称: Mirabegron

描述: Dose-response effect on thermogenesis

合格

标准:

Inclusion Criteria: - Men and women - 18-40 years old - Participate in 150 minutes or more of at least moderate intensity exercise per week during the previous 2 years Exclusion Criteria: - diagnosed autonomic disease - diagnosed cardiovascular disease - diagnosed metabolic disease - diagnosed neurologic disease - diagnosed endocrine disease - diagnosed respiratory disease - diagnosed liver dysfunction - diagnosed kidney dysfunction - Women who are pregnant or breastfeeding - Individuals currently taking a medication (with the exception of birth control, including hormonal contraception) that cannot be safely discontinued for 5 biological half-lifes prior to each study visit based on consultation with the study physician. - Current tobacco or electronic cigarette use or consistent use within the last 1 year

性别: All

最低年龄: 18 Years

最高年龄: 40 Years

健康志愿者: Accepts Healthy Volunteers

总体官员
角色 联系
Blair D Johnson, PhD Principal Investigator Indiana University
总体联系方式

姓: Blair D Johnson, PhD

电话: 8128558699

电子邮件: [email protected]

验证日期

February 2021

责任方

类型: Principal Investigator

研究者隶属关系: Indiana University

调查员全名: Blair D. Johnson

研究者职务: Associate Professor School of Public Health

扩大了访问范围 No
臂数 4
臂组

标签: Placebo

类型: Placebo Comparator

描述: Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room

标签: 100 mg Mirabegron

类型: Experimental

描述: Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room

标签: 150 mg Mirabegron

类型: Experimental

描述: Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room

标签: 200 mg Mirabegron

类型: Experimental

描述: Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room

患者资料 No
研究设计信息

分配: Randomized

干预模式: Crossover Assignment

首要目标: Basic Science

掩蔽: Double (Participant, Investigator)

資料來源:ClinicalTrials.gov

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