Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000688583
Ethics application status
Approved
Date submitted
22/09/2014
Date registered
2/07/2015
Date last updated
2/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study on energy-burning effect of brown fat in humans
Scientific title
Brown Adipose Tissue Thermogenesis in Healthy Humans
Secondary ID [1] 285380 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BATTMAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293113 0
Diabetes 293114 0
Condition category
Condition code
Metabolic and Endocrine 293384 293384 0 0
Metabolic disorders
Diet and Nutrition 293385 293385 0 0
Obesity
Metabolic and Endocrine 293613 293613 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an interventional study examining the relation between brown fat activity and glucose/energy homeostasis.
It involves two half-day studies (4 hours), 1 week apart, measuring brown fat quantity, energy burning rate and hormone levels. Volunteers will be exposed to i) mild cold (between 12 to 19 degree celcius - a personalised temperature in which volunteers feel cool but are no shivering) and also ii) be given 75 g of glucose as a drink to examine effect of cold and glucose on brown fat activity.
Intervention code [1] 290293 0
Other interventions
Comparator / control treatment
Glucose/energy metabolism is compared between individuals with different brown fat quantity and activity. No comparison will be made between different temperatures or before/after food.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293217 0
Glucose tolerance by standard oral glucose tolerance test.
Timepoint [1] 293217 0
Conducted at time 0, 60 and 120 minutes at each visit
Secondary outcome [1] 310606 0
Adipokine profile by serum assay
Timepoint [1] 310606 0
At time 0, 60 and 120 minutes at each visit
Secondary outcome [2] 314840 0
Brown fat quantity assessed by PET scanning
Timepoint [2] 314840 0
At time 120 minutes of each visit
Secondary outcome [3] 314841 0
Energy burning rate by indirect calorimetry
Timepoint [3] 314841 0
At time 0, 60 and 120 minutes of each visit

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Body mass index > 30 kg/m2.
Significant cardiac, respiratory, thyroid, renal and/or hepatic dysfunction

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
i) Exposure to mild cold temperature during PET/CT scanning

ii) oral glucose drink (75g glucose)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All volunteers are exposed to same mild cold and glucose drink.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Unpaired t-tests and ANOVA between variables.
Our pilot data revealed an increase in BAT activity by 9+/-6% (mean +/- standard deviation) following exposure to mild cold condition. Using a two-tailed paired t-test, with a=0.05, and 1-beta =0.8 (power), calculated sample size is N=10. However we are comparing the difference in energy metabolism between brown fat positive and negative individuals. We thus refine sample size calculation based on the more conservative difference in energy expenditure. A total of 14 volunteers will be required to detect a decrease in ~7+/-6% of BAT-related metabolic activity at a two-sided 0.05 significance level with a probability of 80%. Given potential differences between men and women, and to ensure attainment of a final sample size of 14, we have increased the accrual ceiling and will recruit a total of 30 subjects (50% men). This decision takes into consideration potential screening failure.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
28/05/2014
Date of last participant enrolment
Anticipated
31/07/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3008 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 289990 0
Charities/Societies/Foundations
Name [1] 289990 0
Diabetes Australia Research Trust (DART) grant
Country [1] 289990 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Garvan Institute of Medical Research
Address
384 Victoria Street
Darlinghurst
Sydney, NSW 2010
Country
Australia
Secondary sponsor category [1] 288675 0
Hospital
Name [1] 288675 0
St Vincent's Hospital, Sydney
Address [1] 288675 0
380 Victoria Street
Darlinghurst
NSW 2010
Country [1] 288675 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291698 0
St Vincent's Hospital HREC
Ethics committee address [1] 291698 0
Ethics committee country [1] 291698 0
Australia
Date submitted for ethics approval [1] 291698 0
27/01/2014
Approval date [1] 291698 0
11/02/2014
Ethics approval number [1] 291698 0
HREC/13/SVH/377

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51606 0
Dr Paul Lee
Address 51606 0
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
NSW 2010
Country 51606 0
Australia
Phone 51606 0
+61 2 9295 8416
Fax 51606 0
+61 2 9295 8481
Email 51606 0
[email protected]
Contact person for public queries
Name 51607 0
Paul Lee
Address 51607 0
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
NSW 2010
Country 51607 0
Australia
Phone 51607 0
+61 2 9295 8416
Fax 51607 0
+61 2 9295 8481
Email 51607 0
[email protected]
Contact person for scientific queries
Name 51608 0
Paul Lee
Address 51608 0
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
NSW 2010
Country 51608 0
Australia
Phone 51608 0
+61 2 9295 8416
Fax 51608 0
+61 2 9295 8481
Email 51608 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
No additional documents have been identified.