Mirabegron and Physiological Function in Cold Environments

Mirabegron and Physiological Function in Cold Environments

Спонсоры

Ведущий спонсор: Indiana University

Коллаборационист: Office of Naval Research (ONR)

Источник Indiana University
Краткое содержание

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.

Общий статус Not yet recruiting
Дата начала May 2021
Дата завершения May 2023
Дата первичного завершения May 2023
Фаза Phase 1/Phase 2
Тип исследования Interventional
Первичный результат
Мера Временное ограничение
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
Вторичный результат
Мера Временное ограничение
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
Регистрация 30
Состояние
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Mirabegron

Описание: Dose-response effect on thermogenesis

Приемлемость

Критерии:

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

Пол: All

Минимальный возраст: 18 Years

Максимальный возраст: 40 Years

Здоровые волонтеры: Accepts Healthy Volunteers

Общий Официальный
Фамилия Роль Присоединение
Blair D Johnson, PhD Principal Investigator Indiana University
Общий контакт

Фамилия: Blair D Johnson, PhD

Телефон: 8128558699

Эл. адрес: [email protected]

Дата проверки

February 2021

Ответственная сторона

Тип: Principal Investigator

Принадлежность следователя: Indiana University

ФИО следователя: Blair D. Johnson

Должность следователя: Associate Professor School of Public Health

Имеет расширенный доступ No
Количество рук 4
Группа вооружений

Метка: Placebo

Тип: Placebo Comparator

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

Метка: 100 mg Mirabegron

Тип: Experimental

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

Метка: 150 mg Mirabegron

Тип: Experimental

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

Метка: 200 mg Mirabegron

Тип: Experimental

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

Данные пациента No
Информация о дизайне исследования

Распределение: Randomized

Модель вмешательства: Crossover Assignment

Первичное назначение: Basic Science

Маскировка: Double (Participant, Investigator)

Источник: ClinicalTrials.gov

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