None listed
Conditions
Brief summary
Increasing energy expenditure to reverse obesity may be possible using beta-3 adrenergic receptor agonist drugs, however it was not until recently that such drugs have been available under prescription. These approved drugs were developed for purposes other than treatment of obesity, so they have never been studied in this context. In this proposal, we will conduct a pilot study to determine the effects of multiple doses (the highest prescription dose of 50 mg, plus 100, 150 and 200mg) of the beta-3 adrenergic receptor agonist, mirabegron, on whole body energy expenditure and cardiovascular responses. This will be a dose finding study for which the purpose is to obtain data in order to inform a larger trial which will be conducted subsequently. We aim to determine the highest dose which will maximise energy expenditure without effects on the cardiovascular system.
Interventions
This is a dose finding study to determine the dose response to increasing amounts of the beta-3 adrenergic receptor agonist mirabegron (outcome measurements listed subsequently).
Participants will be screened and given a medical assessment by a physician. If cleared for participation the physician will approve a prescription for participants to partake in the drug trials described below.
Participation will involve visiting the laboratory on 4 separate occasions, with each visit involving an or
This is a dose finding study to determine the dose response to increasing amounts of the beta-3 adrenergic receptor agonist mirabegron (outcome measurements listed subsequently). Participants will be screened and given a medical assessment by a physician. If cleared for participation the physician will approve a prescription for participants to partake in the drug trials described below. Participation will involve visiting the laboratory on 4 separate occasions, with each visit involving an oral dose of the drug mirabegron in a multiple ascending dose manner, each separated by between 3-14 days (based on participant availability). The 4 doses will be 50, 100, 150 and 200 mg. Measurements of blood pressure, heart rate and energy expenditure (via indirect calorimetry) will be collected before and at 30 minute intervals after drug ingestion for 3 hours.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
- Aged 18 – 40 years - Not currently taking any prescription medications or other supplements or medications known to alter cardiovascular parameters or increase energy expenditure (as assessed by the study physician during medical screening) - No history of major illness (as assessed by the study physician during medical screening) - BMI equal to or less than 30 kg/m^2
Exclusion criteria
- Hypertension (resting supine blood pressure greater than 140/90 mmHg) - Pregnancy
Outcome results
None listed