Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Placebo
Treatment: Drugs - Ephedrine, pioglitazone

Placebo Comparator: Placebo - lactose powder in equivalent capsule

Experimental: Drug treatment - sympathetic agonist and thiazolidinedione


Treatment: Drugs: Placebo


Treatment: Drugs: Ephedrine, pioglitazone
Intervention code [1] 0 0
Treatment: Drugs
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
Basic Science
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 status
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
Other
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/ct2/show/NCT02236962
Trial related presentations / publications
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/ct2/show/NCT02236962