Mirabegron and Physiological Function in Cold Environments

Mirabegron and Physiological Function in Cold Environments

スポンサー

リードスポンサー: Indiana University

協力者: Office of Naval Research (ONR)

ソース Indiana University
簡単な要約

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.

全体的なステータス Not yet recruiting
開始日 May 2021
完成日 May 2023
一次完成日 May 2023
段階 Phase 1/Phase 2
研究の種類 Interventional
主な結果
測る 時間枠
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
二次転帰
測る 時間枠
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
入学 30
状態
介入

介入タイプ: Drug

介入名: Mirabegron

説明文: Dose-response effect on thermogenesis

適格性

基準:

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

性別: All

最低年齢: 18 Years

最大年齢: 40 Years

健康なボランティア: Accepts Healthy Volunteers

全体的な公式
苗字 役割 所属
Blair D Johnson, PhD Principal Investigator Indiana University
全体的な連絡先

苗字: Blair D Johnson, PhD

電話: 8128558699

Eメール: [email protected]

確認日

February 2021

責任者

タイプ: Principal Investigator

調査官の所属: Indiana University

調査官の氏名: Blair D. Johnson

調査官の肩書: Associate Professor School of Public Health

アクセスを拡大しました No
腕の数 4
アームグループ

ラベル: Placebo

タイプ: Placebo Comparator

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

ラベル: 100 mg Mirabegron

タイプ: Experimental

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

ラベル: 150 mg Mirabegron

タイプ: Experimental

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

ラベル: 200 mg Mirabegron

タイプ: Experimental

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

患者データ No
研究デザイン情報

割り当て: Randomized

介入モデル: Crossover Assignment

主な目的: Basic Science

マスキング: Double (Participant, Investigator)

出典:ClinicalTrials.gov

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