Mirabegron and Physiological Function in Cold Environments

NCT04766021 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2011690870; Aim 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 determining which dose of mirabegron administration will increase thermogenesis during 6 hours of a mild cold stress challenge. This study is part of a collection of studies that 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.

Conditions

Resting Energy Expenditure; Thermogenesis; Brown Adipose Tissue

Outcome Measures

Primary Outcomes (1)

• Cumulative Resting Energy Expenditure

  The cumulative resting energy expenditure will be calculated to reflect the cumulative effect of mirabegron over time.

  360 minutes

Secondary Outcomes (9)

• Core Body Temperature

  Baseline and every 30 minutes through 360 minutes

• Brown Adipose Tissue Activation

  Baseline and hourly through 360 minutes

• Weighted Mean Skin Temperature

  Baseline and every 30 minutes through 360 minutes

• Heart Rate

  Baseline and every 30 minutes through 360 minutes

• Mean Arterial Pressure

  Baseline and every 30 minutes through 360 minutes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

100 mg Mirabegron

EXPERIMENTAL

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

Drug: Mirabegron

150 mg Mirabegron

EXPERIMENTAL

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

Drug: Mirabegron

200 mg Mirabegron

EXPERIMENTAL

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

Drug: Mirabegron

Interventions

Mirabegron DRUG

Dose-response effect on thermogenesis

Also known as: Myrbetriq

100 mg Mirabegron; 150 mg Mirabegron; 200 mg Mirabegron

Placebo DRUG

Placebo control condition

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women
• years old
• Participate in 150 minutes or more of at least moderate intensity exercise per week during the previous 2 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Office of Naval Research (ONR): collaborator

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Interventions

mirabegron

Results Point of Contact

• Title: Dr. Blair Johnson
• Organization: Indiana University

bj33@indiana.edu

8128558699

Study Officials

• Blair D Johnson, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor School of Public Health

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 23, 2021
• Study Start: November 30, 2021
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)