Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06011265 |
Other study ID # |
2981 |
Secondary ID |
|
Status |
Completed |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
April 27, 2023 |
Est. completion date |
April 30, 2024 |
Study information
Verified date |
June 2024 |
Source |
Colorado State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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.
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.