Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000542392
Ethics application status
Approved
Date submitted
3/04/2017
Date registered
18/04/2017
Date last updated
15/02/2019
Date data sharing statement initially provided
15/02/2019
Date results information initially provided
15/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Blood pressure, heart rate and energy expenditure effects of the drug mirabegron.
Scientific title
Metabolic and cardiovascular responses to a beta-3 adrenergic receptor drug in healthy adults.
Secondary ID [1] 291604 0
Nil known
Universal Trial Number (UTN)
U1111-1195-0358
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Obesity 302718 0
Condition category
Condition code
Metabolic and Endocrine 302240 302240 0 0
Metabolic disorders
Diet and Nutrition 302265 302265 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297673 0
Treatment: Drugs
Comparator / control treatment
Dose comparison (between all 4 different doses).
Control group
Dose comparison

Outcomes
Primary outcome [1] 301647 0
Energy expenditure via indirect calorimetry
Timepoint [1] 301647 0
Energy expenditure will be assessed by measurement for 10 minutes before administering the drug dose, then for 10 minutes, every 30 minutes (eg, from 20-30 min, 50-60 min, 80-90 min, and so on) until 3 hours (from 170-180 minutes) post dosing. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion.
Secondary outcome [1] 333436 0
heart rate via an automated sphygmomanometer
Timepoint [1] 333436 0
Heart rate will be assessed by measurement before administering the drug dose, then every 30 minutes post dosing for 3 hours. Each individual measurement will take approximately 30 seconds. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion.
Secondary outcome [2] 333437 0
Blood pressure via an automated sphygmomanometer
Timepoint [2] 333437 0
Blood pressure will be assessed by measurement before administering the drug dose, then every 30 minutes post dosing for 3 hours. Each individual measurement will take approximately 30 seconds. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Hypertension (resting supine blood pressure greater than 140/90 mmHg)
- Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Repeated measures ANOVA will be used to determine whether differences exist between treatment doses for the key outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/04/2017
Date of last participant enrolment
Anticipated
19/11/2018
Actual
31/07/2017
Date of last data collection
Anticipated
17/12/2018
Actual
27/10/2017
Sample size
Target
30
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7767 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 15700 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 296091 0
Other
Name [1] 296091 0
Baker Heart and Diabetes Institute
Country [1] 296091 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
PO Box 6492
Melbourne, Vic
3004
Country
Australia
Secondary sponsor category [1] 294987 0
None
Name [1] 294987 0
Address [1] 294987 0
Country [1] 294987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297347 0
Alfred Hospital Human Ethics Committee
Ethics committee address [1] 297347 0
Old Baker Building, Level 1,
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 297347 0
Australia
Date submitted for ethics approval [1] 297347 0
18/01/2017
Approval date [1] 297347 0
31/03/2017
Ethics approval number [1] 297347 0
047/17

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73774 0
Dr Andrew Carey
Address 73774 0
Baker Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic
3004
Country 73774 0
Australia
Phone 73774 0
61 3 8532 1251
Fax 73774 0
Email 73774 0
[email protected]
Contact person for public queries
Name 73775 0
Andrew Carey
Address 73775 0
Baker Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic
3004
Country 73775 0
Australia
Phone 73775 0
61 3 8532 1251
Fax 73775 0
Email 73775 0
[email protected]
Contact person for scientific queries
Name 73776 0
Andrew Carey
Address 73776 0
Baker Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic
3004
Country 73776 0
Australia
Phone 73776 0
61 3 8532 1251
Fax 73776 0
Email 73776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Loh RKC, Formosa MF, La Gerche A, Reutens AT, King... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcute metabolic and cardiovascular effects of mirabegron in healthy individuals.2019https://dx.doi.org/10.1111/dom.13516
N.B. These documents automatically identified may not have been verified by the study sponsor.