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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
Scientific title
Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment
Secondary ID [1] 0 0
15-12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Obesity 0 0
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placebo comparator: Placebo - lactose powder in equivalent capsule

Experimental: Drug treatment - sympathetic agonist and thiazolidinedione
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
brown adipose tissue activity
Timepoint [1] 0 0
3 years

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
Minimum age
19 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Baker Heart and Diabetes Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Alfred
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02236962
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melissa F Formosa, B Sci
Address 0 0
Country 0 0
Phone 0 0
+61 9076 1652
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02236962