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100 mg Mirabegron for Resting Metabolic Rate
Phase 1 & 2
Waitlist Available
Led By Blair D Johnson, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through session completion, up to 4 hours
Awards & highlights
Study Summary
This trial will investigate if mirabegron can improve cold water tolerance for Navy divers, helping them stay warm and complete successful missions.
Who is the study for?
This trial is for men and women aged 18-40 who exercise regularly (at least 150 minutes of moderate intensity per week) over the past two years. It's not for those on certain meds they can't stop, with heart, metabolic, liver or kidney issues, pregnant or breastfeeding women, tobacco users within a year, or people with neurological, endocrine, autonomic or respiratory diseases.Check my eligibility
What is being tested?
The study tests if Mirabegron can help Navy divers tolerate cold water better by activating brown fat to generate heat. Participants will either get Mirabegron or a placebo to see if it delays getting cold and shivering during cold-water immersion challenges.See study design
What are the potential side effects?
Mirabegron may cause increased blood pressure and heart rate; it might also lead to urinary tract infections (UTIs), headaches, dizziness, joint pain or digestive problems like nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through session completion, up to 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through session completion, up to 4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cold temperature deflection point
Secondary outcome measures
Shivering Inflection point - Bedside Shivering Scale
Shivering inflection point - Surface Mechanomyography
Thermogenesis - Oxygen Consumption
Side effects data
From 2019 Phase 4 trial • 28 Patients • NCT020861887%
urinary tract infection
7%
gastritis
7%
fatigue
7%
asthma
7%
diarrhea
7%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mirabegron
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 100 mg MirabegronExperimental Treatment1 Intervention
Given once, followed by observation for up to 4 hours in a progressively cold water challenge
Group II: PlaceboPlacebo Group1 Intervention
Given once, followed by observation for up to 4 hours in a progressively cold water challenge
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron
2008
Completed Phase 4
~18640
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Indiana UniversityLead Sponsor
982 Previous Clinical Trials
981,160 Total Patients Enrolled
Office of Naval Research (ONR)FED
14 Previous Clinical Trials
692 Total Patients Enrolled
Blair D Johnson, PhDPrincipal InvestigatorIndiana University
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a heart condition.I have been diagnosed with a metabolic disease.I have been diagnosed with a neurological condition.I am not pregnant or breastfeeding.I can stop my current medications, except for birth control, for the required period before each study visit.I have been diagnosed with a disorder affecting my autonomic nervous system.I am between 18 and 40 years old.I have been diagnosed with a lung or breathing condition.I have been diagnosed with a hormone-related disease.I have been diagnosed with liver problems.I have been diagnosed with kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: 100 mg Mirabegron
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age criteria for this test open to individuals aged fifty and above?
"This medical trial stipulates that participants must be aged between 18 and 40 as part of the eligibility requirements."
Answered by AI
What is the estimated magnitude of participants in this exploration?
"Affirmative. Clinicaltrials.gov has confirmed that the trial initially announced on July 19th 2023 is still actively recruiting patients, with 30 participants sought from one clinic site. The details of this study were last updated on August 4th 2023."
Answered by AI
Does this clinical trial still accept new participants?
"Absolutely, the records on clinicaltrials.gov suggest that this research is actively seeking recruits. The trial was initiated on July 19th of 2023 and modified later in August 4th of the same year. 30 patients are required for participation across a single site."
Answered by AI
Am I eligible to contribute to this medical experiment?
"To qualify for this research, applicants should have a basal metabolic rate and an age between 18 to 40 years old. The investigators are seeking around 30 participants."
Answered by AI
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