Trial Outcomes & Findings for Mirabegron and Physiological Function in Cold Environments (NCT NCT04766021)
NCT ID: NCT04766021
Last Updated: 2024-07-12
Results Overview
The cumulative resting energy expenditure will be calculated to reflect the cumulative effect of mirabegron over time.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
360 minutes
Results posted on
2024-07-12
Participant Flow
This is a repeated measures study design. 30 subjects provided written informed consent. Of these subjects: 9 voluntarily withdrew (4 provided no reason, 5 withdrew due to time commitment); 10 met exclusion criteria; 11 completed the informed consent/screening visit. All 11 subjects that completed the informed consent/screening visit also completed all four arms of the study.
Participant milestones
| Measure |
Randomized: Placebo, 100 mg Mirabegron, 150 mg Mirabegron, 200 mg Mirabegron
Study drug/placebo given at baseline, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Four encapsulated placebo tablets 100 mg mirabegron: Two 50 mg mirabegron encapsulated tablets and two placebo encapsulated tablets 150 mg mirabegron: Three 50 mg mirabegron encapsulated tablets and one placebo encapsulated tablet 200 mg mirabegron: Four 50 mg mirabegron encapsulated tablets and one placebo encapsulated tablet
|
|---|---|
|
Informed Consent/Screening Visit
STARTED
|
30
|
|
Informed Consent/Screening Visit
COMPLETED
|
11
|
|
Informed Consent/Screening Visit
NOT COMPLETED
|
19
|
|
Interventions
STARTED
|
11
|
|
Interventions
COMPLETED
|
11
|
|
Interventions
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Randomized: Placebo, 100 mg Mirabegron, 150 mg Mirabegron, 200 mg Mirabegron
Study drug/placebo given at baseline, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Four encapsulated placebo tablets 100 mg mirabegron: Two 50 mg mirabegron encapsulated tablets and two placebo encapsulated tablets 150 mg mirabegron: Three 50 mg mirabegron encapsulated tablets and one placebo encapsulated tablet 200 mg mirabegron: Four 50 mg mirabegron encapsulated tablets and one placebo encapsulated tablet
|
|---|---|
|
Informed Consent/Screening Visit
Withdrawal by Subject
|
9
|
|
Informed Consent/Screening Visit
Met exclusion criteria
|
10
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Randomized: Placebo, 100 mg Mirabegron, 150 mg Mirabegron, 200 mg Mirabegron
n=11 Participants
Placebo: given once Mirabegron: 100 mg given once Mirabegron: 150 mg given once Mirabegron: 200 mg given once
Participants completed each condition in a randomized order separated by 10-14 days. After placebo or mirabegron ingestion, participants were observed for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room.
|
|---|---|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 2 • n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
|
Body Mass Index
|
25 kg/m2
STANDARD_DEVIATION 4 • n=11 Participants
|
PRIMARY outcome
Timeframe: 360 minutesThe cumulative resting energy expenditure will be calculated to reflect the cumulative effect of mirabegron over time.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Cumulative Resting Energy Expenditure
|
456.4 kcal
Standard Deviation 67.8
|
494.7 kcal
Standard Deviation 75.7
|
481.3 kcal
Standard Deviation 67.2
|
492.8 kcal
Standard Deviation 69.8
|
SECONDARY outcome
Timeframe: Baseline and every 30 minutes through 360 minutesCore Body temperature will be measured via rectal temperature during the experiment. The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Core Body Temperature
|
36.87 degrees C
Standard Deviation 0.03
|
36.78 degrees C
Standard Deviation 0.02
|
36.85 degrees C
Standard Deviation 0.04
|
36.76 degrees C
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline and hourly through 360 minutesInfrared thermography will be used to measure supraclavicular skin temperature as an estimate of brown adipose tissue activation. The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Brown Adipose Tissue Activation
|
34.56 degrees C
Standard Deviation 0.25
|
34.49 degrees C
Standard Deviation 0.23
|
34.45 degrees C
Standard Deviation 0.25
|
34.45 degrees C
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline and every 30 minutes through 360 minutesFourteen iButtons will be adhered to the skin using adhesive tape on the calf, shin, front thigh, back thigh, foot, chest, upper back, lower back, forearm, hand, forehead, fingertip, toetip, and abdomen area to measure weighted skin temperature. Temperature readings will be taken every 30 minutes during the experiment. The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Weighted Mean Skin Temperature
|
30.58 degrees C
Standard Deviation 0.29
|
30.64 degrees C
Standard Deviation 0.28
|
30.43 degrees C
Standard Deviation 0.35
|
30.75 degrees C
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Baseline and every 30 minutes through 360 minutesHeart rate will be obtained using a 3-lead electrocardiogram. The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Heart Rate
|
64 beats/minute
Standard Deviation 2
|
69 beats/minute
Standard Deviation 3
|
67 beats/minute
Standard Deviation 2
|
68 beats/minute
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline and every 30 minutes through 360 minutesBlood pressure will be monitored using a cuff placed on the upper arm that is inflated and deflated periodically. The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Mean Arterial Pressure
|
92.5 mmHg
Standard Deviation 1.8
|
94.4 mmHg
Standard Deviation 2.3
|
95.4 mmHg
Standard Deviation 2.6
|
95.0 mmHg
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline and every 30 minutes through 360 minutesA pneumotach connected to a mouthpiece or facemask will be used to measure the flow of inspired and expired air. Expired gases will be sampled using oxygen and carbon dioxide sensors to determine oxygen consumption and carbon dioxide production. The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Relative Oxygen Consumption
|
3.59 ml O2 / kg body mass / minute
Standard Deviation 0.12
|
3.89 ml O2 / kg body mass / minute
Standard Deviation 0.20
|
3.83 ml O2 / kg body mass / minute
Standard Deviation 0.22
|
3.89 ml O2 / kg body mass / minute
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Baseline and every 30 minutes through 360 minutesTwo investigators will subjectively assess shivering by the participants using a Likert scale (range 0-3; 0 = none, 3 = Severe) and the scores will be averaged. The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Bedside Shivering Scale
|
0.06 units on a scale
Standard Deviation 0.22
|
0.04 units on a scale
Standard Deviation 0.18
|
0.02 units on a scale
Standard Deviation 0.11
|
0.03 units on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline and every 30 minutes through 360 minutesParticipants will complete a Likert scale to assess their thermal comfort (range: 1-4; 1 = comfortable, 4 = very uncomfortable).The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Thermal Comfort Scale
|
2.1 units on a scale
Standard Deviation 0.3
|
1.9 units on a scale
Standard Deviation 0.3
|
1.9 units on a scale
Standard Deviation 0.2
|
1.8 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline and every 30 minutes through 360 minutesParticipants will complete a Likert scale to assess their thermal sensation (range: 1-7; 1 = cold, 4 = neutral, 7 = hot). The mean value was calculated.
Outcome measures
| Measure |
Placebo
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Placebo: Placebo control condition
|
100 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
150 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
200 mg Mirabegron
n=11 Participants
Given once, followed by observation for 6 hours in a 20 degree Celsius (68 degree Fahrenheit) room
Mirabegron: Dose-response effect on thermogenesis
|
|---|---|---|---|---|
|
Thermal Sensation Scale
|
2.4 units on a scale
Standard Deviation 0.4
|
2.8 units on a scale
Standard Deviation 0.3
|
2.7 units on a scale
Standard Deviation 0.3
|
2.8 units on a scale
Standard Deviation 0.3
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg Mirabegron
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
150 mg Mirabegron
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 mg Mirabegron
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place