Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000161022
Ethics application status
Approved
Date submitted
15/02/2010
Date registered
18/02/2010
Date last updated
18/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adrenergic control of protein and fat metabolism in healthy adults
Scientific title
Impact of beta2-adrenergic stimulation on protein and fat metabolism in healthy adults
Secondary ID [1] 1417 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 256823 0
Condition category
Condition code
Metabolic and Endocrine 256972 256972 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral administration of a beta2-agonist (oral formoterol tablet 160 mg daily for 1 week)
Intervention code [1] 256027 0
Treatment: Drugs
Intervention code [2] 256039 0
Prevention
Comparator / control treatment
Changes in metabolism are compared before and after treatment in the same subject
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257857 0
energy expenditure by calorimetry
Timepoint [1] 257857 0
baseline and 1 week
Primary outcome [2] 257858 0
protein turnover by blood analysis
Timepoint [2] 257858 0
baseline and 1 week after treatment
Secondary outcome [1] 263315 0
Nil
Timepoint [1] 263315 0
Nil

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
20 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any active medical conditions necessitating medication

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are screened for eligibility by clinical history, physical examination and laboratory blood tests (full blood count, renal function, liver function). Eligible subjects are invited to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256525 0
Government body
Name [1] 256525 0
National Health and Medical Research Council
Country [1] 256525 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
National Health and Medical Research Council
National Institute of Clinical Studies
GPO Box 4530
Melbourne Vic 3001
Country
Australia
Secondary sponsor category [1] 255834 0
None
Name [1] 255834 0
Address [1] 255834 0
Country [1] 255834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258573 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 258573 0
St Vincent's Hospital
Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 258573 0
Australia
Date submitted for ethics approval [1] 258573 0
Approval date [1] 258573 0
30/06/2009
Ethics approval number [1] 258573 0
1/09/0060

Summary
Brief summary
The study objective is to investigate the metabolic effects of beta2-agonist in humans, including whole body energy expenditure, fat oxidation, protein synthesis and turnover
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 30850 0
Address 30850 0
Country 30850 0
Phone 30850 0
Fax 30850 0
Email 30850 0
Contact person for public queries
Name 14097 0
Paul Lee
Address 14097 0
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
New South Wales 2010
Country 14097 0
Australia
Phone 14097 0
+61 2 9295 8486
Fax 14097 0
+61 2 9295 8481
Email 14097 0
[email protected]
Contact person for scientific queries
Name 5025 0
Paul Lee
Address 5025 0
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
New South Wales 2010
Country 5025 0
Australia
Phone 5025 0
+61 2 9295 8486
Fax 5025 0
+61 2 9295 8481
Email 5025 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFormoterol, a highly beta2-selective agonist, induces gender-dimorphic whole body leucine metabolism in humans.2015https://dx.doi.org/10.1016/j.metabol.2014.12.005
N.B. These documents automatically identified may not have been verified by the study sponsor.