Does Mirabegron Increase the Body Heat Generated by the Nervous System

NCT06011265 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2981
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thermoregulation

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Immediately after each infusion.

Study Arms (2)

Mirabegron + Isoproterenol

EXPERIMENTAL

100mg oral + Isoproterenol IV Infusion; 3 doses, 6, 12, 24ng/ kg Fat Free Mass

Drug: Myrbetriq 25Mg Extended-Release Tablet

Placebo + Isoproterenol

PLACEBO COMPARATOR

Empty Capsule + Isoproterenol IV Infusion; 3 doses, 6, 12, 24ng/ kg Fat Free Mass

Drug: Placebo

Interventions

Myrbetriq 25Mg Extended-Release Tablet DRUG

Participants take 4x 25mg Myrbetriq 25Mg Extended-Release Tablet orally.

Mirabegron + Isoproterenol

Placebo DRUG

Participants take empty capsule orally

Placebo + Isoproterenol

Eligibility Criteria

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

You may qualify if:

• age 18-40 years,
• regular participation in more than 150 minutes of moderate intensity exercise, every week, during the previous two years.

You may not qualify if:

• 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 '

Sponsors & Collaborators

• Christopher Bell: lead
• Indiana University: collaborator

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

MeSH Terms

Interventions

mirabegron

Study Officials

• Christopher Bell, Ph.D.

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Crossover with a washout of at least 10 days

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 25, 2023
• Study Start: April 27, 2023
• Primary Completion: January 17, 2024
• Study Completion: April 30, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)