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NCT04766021 · ClinicalTrials.gov registry record · Phase 1
Mirabegron and Physiological Function in Cold Environments
A Phase 1 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04766021: Completed Phase 1 study, sponsored by Indiana University.
NCT04766021 is a Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04766021, a Phase 1 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
The cumulative resting energy expenditure will be calculated to reflect the cumulative effect of mirabegron over time.
Interventions
- DRUG Placebo
- DRUG Mirabegron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2023-04-27 |
| Phase | Phase 1 |
What the finished NCT04766021 record still lists
NCT04766021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04766021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04766021 about?
NCT04766021 is a clinical study titled "Mirabegron and Physiological Function in Cold Environments". 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 ...
What is the current status of trial NCT04766021?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-11-30. Estimated completion is 2023-04-27.
What interventions are being tested in trial NCT04766021?
The interventions under investigation include: Placebo (DRUG), Mirabegron (DRUG).
Who is sponsoring clinical trial NCT04766021?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04766021's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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