Clinical trial

Does Mirabegron Increase the Body Heat Generated by the Nervous System

Name
2981
Description
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.
Trial arms
Trial start
2023-04-27
Estimated PCD
2024-01-17
Trial end
2024-04-30
Status
Completed
Phase
Early phase I
Treatment
Myrbetriq 25Mg Extended-Release Tablet
Participants take 4x 25mg Myrbetriq 25Mg Extended-Release Tablet orally.
Arms:
Mirabegron + Isoproterenol
Placebo
Participants take empty capsule orally
Arms:
Placebo + Isoproterenol
Size
19
Primary endpoint
Change in metabolic rate compared to baseline during each stage as measured by indirect calorimetry
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.
Immediately after each infusion.
Change in core temperature measured via oral thermometer during each stage.
Immediately after each infusion.
Eligibility criteria
Inclusion Criteria: * age 18-40 years, * regular participation in more than 150 minutes of moderate intensity exercise, every week, during the previous two years. Exclusion Criteria: * 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 '
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover with a washout of at least 10 days', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Single Blind', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2024-06-06

1 organization

2 products

1 indication

Organization
Christopher Bell
Product
Myrbetriq
Product
Placebo