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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02236962
Registration number
NCT02236962
Ethics application status
Date submitted
30/01/2012
Date registered
11/09/2014
Date last updated
11/09/2014
Titles & IDs
Public title
Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment
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Scientific title
Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment
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Secondary ID [1]
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15-12
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Obesity
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Cardiovascular Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Placebo comparator: Placebo - lactose powder in equivalent capsule
Experimental: Drug treatment - sympathetic agonist and thiazolidinedione
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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brown adipose tissue activity
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Assessment method [1]
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measured via PET-CT
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Timepoint [1]
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3 years
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Eligibility
Key inclusion criteria
* Males aged 19 - 35 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Unmedicated
* No major illness
* BMI <27 kg/m2
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Minimum age
19
Years
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Maximum age
35
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Unable to give informed consent
* Smokers
* Participant in research projects involving ionising radiation within the past 5 years.
* Claustrophobia
* Fasting plasma glucose > 6.0 mmol/L
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
42
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Baker Heart and Diabetes Institute
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The Alfred
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Obesity is epidemic in Australia, and current preventative strategies have had limited success in alleviating this health crisis. While numerous options are available for treatment of obesity, most do not result in sustained weight reduction. Obesity results from an imbalance between energy intake and expenditure, therefore new methods that correct this imbalance are essential for effective long-term treatment. Rodent studies show that brown adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore targeting BAT to increase its activity (energy burning rate) and quantity in humans is potentially a powerful tool for the treatment of obesity and related diseases. BAT has only recently been irrefutably identified in adult humans therefore little is known about how it functions in humans.
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Trial website
https://clinicaltrials.gov/study/NCT02236962
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Trial related presentations / publications
Loh RKC, Formosa MF, Eikelis N, Bertovic DA, Anderson MJ, Barwood SA, Nanayakkara S, Cohen ND, La Gerche A, Reutens AT, Yap KS, Barber TW, Lambert GW, Cherk MH, Duffy SJ, Kingwell BA, Carey AL. Pioglitazone reduces cold-induced brown fat glucose uptake despite induction of browning in cultured human adipocytes: a randomised, controlled trial in humans. Diabetologia. 2018 Jan;61(1):220-230. doi: 10.1007/s00125-017-4479-9. Epub 2017 Oct 18. Erratum In: Diabetologia. 2018 Feb;61(2):504-505. doi: 10.1007/s00125-017-4514-x. Carey AL, Pajtak R, Formosa MF, Van Every B, Bertovic DA, Anderson MJ, Eikelis N, Lambert GW, Kalff V, Duffy SJ, Cherk MH, Kingwell BA. Chronic ephedrine administration decreases brown adipose tissue activity in a randomised controlled human trial: implications for obesity. Diabetologia. 2015 May;58(5):1045-54. doi: 10.1007/s00125-015-3543-6. Epub 2015 Mar 1.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Melissa F Formosa, B Sci
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Address
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Country
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Phone
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+61 9076 1652
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Fax
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Email
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[email protected]
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02236962
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