ThermoregulationEarly Phase 1NCT06011265
Does Mirabegron Increase the Body Heat Generated by the Nervous System
A Early Phase 1 study testing Myrbetriq 25Mg Extended-Release Tablet in people with Thermoregulation, run by Christopher Bell at 1 site in United States.
Trial summary
Acute mirabegron administration has been shown to increase brown fat activity in humans. Long-term mirabegron administration upregulates brown fat, and appears to improve glucose regulation, and change skeletal muscle phenotype. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Thermoregulation
- What is being tested?
- Myrbetriq 25Mg Extended-Release Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 30 Apr 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-40 years,
- regular participation in more than 150 minutes of moderate intensity exercise, every week, during the previous two years.
Who cannot join
- History of autonomic, cardio-pulmonary, and/or metabolic disease (including heart failure, hypertension, arrhythmia, vascular disease, and/or diabetes)
- contraindication for mirabegron ingestion, such as previously diagnosed liver and/or kidney dysfunction,
- use of medication that may unfavorably interact with mirabegron, including thioridazine (Mellaril™ and Mellaril-S™), flecainide (Tambocor®), propafenone (Rythmol®), digoxin (Lanoxin®) and solifenacin succinate (VESIcare®)
- pregnancy or breast feeding
- habitual use of tobacco/nicotine products (2 or more uses within the previous month)
- any type of bladder dysfunction, taking medication related to bladder issues, or a history of bladder issues.
- Sulfite Allergy '
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
Acute mirabegron administration has been shown to increase brown fat activity in humans. Long-term mirabegron administration upregulates brown fat, and appears to improve glucose regulation, and change skeletal muscle phenotype.
Read the detailed description
The Undersea Medicine Program at the Office of Naval Research has invited Indiana University, Rutgers and Colorado State University, to explore the potential of the medication, Mirabegron, to improve the cold tolerance of Navy personnel. Indiana University will submit the formal application for research funding. Research activities at Colorado State University will be supported by a sub-contact from Indiana University.
The project will address four hypotheses. One of these hypotheses will be investigated exclusively at Colorado State University during the second year of the project. The proposed activities at Colorado State University will be unique; the link to activities performed by Indiana University and Rutgers is thematic only.
Specialized Navy personnel are required to undertake duties while immersed in cold water for prolonged periods. These dives regularly require the use of external thermal protection (i.e., wet suits and dry suits). However, external thermal protection during prolonged cold-water diving is often times insufficient to maintain body temperature and thermal comfort, thereby potentially negatively impacting the safety and success of diving missions. Accordingly, developing an alternative strategy that can improve tolerance to cold-water immersion is of important interest to Navy divers and special forces. In this regard, the pharmaceutical, mirabegron, may hold considerable promise to mitigate the negative effects of cold-water immersion on cold-water tolerance by increasing thermogenesis (the generation of heat). Mirabegron (Myrbetriq®, extended-release tablet, Astellas Pharma), is a medication approved by the Food and Drug Administration for the treatment of overactive bladder. In 2020, it was the 160th most commonly prescribed medication in the United States, with more than three million prescriptions. The mechanism of action is stimulation of beta-3-adrenergic receptors (receptors that are usually stimulated by the sympathetic nervous system). Mirabegron is also known to stimulate brown fat, a metabolically active, heat-generating tissue. The overall goals of the project are to determine the efficacy of acute mirabegron administration to improve cold tolerance and determine if mirabegron can accentuate thermogenesis during sympathetic activation.
- Conditions
- Thermoregulation
- Being tested
- Myrbetriq 25Mg Extended-Release Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myrbetriq 25Mg Extended-Release TabletDrug
Participants take 4x 25mg Myrbetriq 25Mg Extended-Release Tablet orally.
PlaceboDrug
Participants take empty capsule orally
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron + Isoproterenol | Experimental | 100mg oral + Isoproterenol IV Infusion; 3 doses, 6, 12, 24ng/ kg Fat Free Mass Receives: Drug: Myrbetriq 25Mg Extended-Release Tablet |
| Placebo + Isoproterenol | Placebo comparator | Empty Capsule + Isoproterenol IV Infusion; 3 doses, 6, 12, 24ng/ kg Fat Free Mass Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic rate compared to baseline during each stage as measured by indirect calorimetry
Participants will undergo a 45 minute resting metabolic rate assessment and then consume Mirabegron or Placebo. Afterwards, they will undergo three 30 minute infusions of Isoproterenol consisting of doses of 6, 12, and 24ng/kg FFM
Measured: Immediately after each infusion
Change in temperature among the top 10% of hottest pixels as identified via thermal camera and FLIR research software in the supraclavicular region during each isoproterenol infusion.
At the conclusion of each of the 3 isoproterenol infusions, participants will have thermal images taken of their supraclavicular region to identify brown fat activation.
Measured: Immediately after each infusion.
Change in core temperature measured via oral thermometer during each stage.
Core temperature will be measured via oral thermometer at the conclusion of each of the three isoproterenol infusions.
Measured: Immediately after each infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start27 Apr 2023
- Primary completion17 Jan 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThermoregulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover with a washout of at least 10 days
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Bell
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor-investigator, Christopher Bell, Colorado State University
- Investigators
- Christopher Bell, Ph.D., Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011265
- Sponsor's protocol ID
- 2981
- Status last verified
- Jun 2024
- First submitted
- 24 Jul 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Mirabegron Increase the Body Heat Generated by the Nervous System
- ClinicalTrials.gov ID
- NCT06011265
- Acronym / sponsor ID
- 2981
- Conditions
- Thermoregulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Christopher BellUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute mirabegron administration has been shown to increase brown fat activity in humans. Long-term mirabegron administration upregulates brown fat, and appears to improve glucose regulation, and change skeletal muscle phenotype.
Detailed description
The Undersea Medicine Program at the Office of Naval Research has invited Indiana University, Rutgers and Colorado State University, to explore the potential of the medication, Mirabegron, to improve the cold tolerance of Navy personnel. Indiana University will submit the formal application for research funding. Research activities at Colorado State University will be supported by a sub-contact from Indiana University.
The project will address four hypotheses. One of these hypotheses will be investigated exclusively at Colorado State University during the second year of the project. The proposed activities at Colorado State University will be unique; the link to activities performed by Indiana University and Rutgers is thematic only.
Specialized Navy personnel are required to undertake duties while immersed in cold water for prolonged periods. These dives regularly require the use of external thermal protection (i.e., wet suits and dry suits). However, external thermal protection during prolonged cold-water diving is often times insufficient to maintain body temperature and thermal comfort, thereby potentially negatively impacting the safety and success of diving missions. Accordingly, developing an alternative strategy that can improve tolerance to cold-water immersion is of important interest to Navy divers and special forces. In this regard, the pharmaceutical, mirabegron, may hold considerable promise to mitigate the negative effects of cold-water immersion on cold-water tolerance by increasing thermogenesis (the generation of heat). Mirabegron (Myrbetriq®, extended-release tablet, Astellas Pharma), is a medication approved by the Food and Drug Administration for the treatment of overactive bladder. In 2020, it was the 160th most commonly prescribed medication in the United States, with more than three million prescriptions. The mechanism of action is stimulation of beta-3-adrenergic receptors (receptors that are usually stimulated by the sympathetic nervous system). Mirabegron is also known to stimulate brown fat, a metabolically active, heat-generating tissue. The overall goals of the project are to determine the efficacy of acute mirabegron administration to improve cold tolerance and determine if mirabegron can accentuate thermogenesis during sympathetic activation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover with a washout of at least 10 days
| Arm | Type | Receives |
|---|---|---|
| Mirabegron + Isoproterenol | Experimental | Drug: Myrbetriq 25Mg Extended-Release Tablet100mg oral + Isoproterenol IV Infusion; 3 doses, 6, 12, 24ng/ kg Fat Free Mass |
| Placebo + Isoproterenol | Placebo comparator | Drug: PlaceboEmpty Capsule + Isoproterenol IV Infusion; 3 doses, 6, 12, 24ng/ kg Fat Free Mass |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-40 years,
- regular participation in more than 150 minutes of moderate intensity exercise, every week, during the previous two years.
Key exclusion criteria (7 listed)
- History of autonomic, cardio-pulmonary, and/or metabolic disease (including heart failure, hypertension, arrhythmia, vascular disease, and/or diabetes)
- contraindication for mirabegron ingestion, such as previously diagnosed liver and/or kidney dysfunction,
- use of medication that may unfavorably interact with mirabegron, including thioridazine (Mellaril™ and Mellaril-S™), flecainide (Tambocor®), propafenone (Rythmol®), digoxin (Lanoxin®) and solifenacin succinate (VESIcare®)
- pregnancy or breast feeding
- habitual use of tobacco/nicotine products (2 or more uses within the previous month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myrbetriq 25Mg Extended-Release TabletParticipants take 4x 25mg Myrbetriq 25Mg Extended-Release Tablet orally. | Drug | Mirabegron + Isoproterenol |
| PlaceboParticipants take empty capsule orally | Drug | Placebo + Isoproterenol |
Primary outcome
Change in metabolic rate compared to baseline during each stage as measured by indirect calorimetry
Time frame: Immediately after each infusion
Participants will undergo a 45 minute resting metabolic rate assessment and then consume Mirabegron or Placebo. Afterwards, they will undergo three 30 minute infusions of Isoproterenol consisting of doses of 6, 12, and 24ng/kg FFM
Change in temperature among the top 10% of hottest pixels as identified via thermal camera and FLIR research software in the supraclavicular region during each isoproterenol infusion.
Time frame: Immediately after each infusion.
At the conclusion of each of the 3 isoproterenol infusions, participants will have thermal images taken of their supraclavicular region to identify brown fat activation.
Change in core temperature measured via oral thermometer during each stage.
Time frame: Immediately after each infusion.
Core temperature will be measured via oral thermometer at the conclusion of each of the three isoproterenol infusions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Bell, Ph.D. principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Myrbetriq 25Mg Extended-Release Tablet in people with Thermoregulation, run by Christopher Bell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in metabolic rate compared to baseline during each stage as measured by indirect calorimetry (time frame: Immediately after each infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.