Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001198910
Ethics application status
Approved
Date submitted
17/11/2011
Date registered
22/11/2011
Date last updated
22/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Physiology of brown fat in humans
Scientific title
Impact of beta-adrenergic agents, sex steroids, growth hormone and corticosteroids on brown fat activity in adult humans
Secondary ID [1] 273406 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 279188 0
Condition category
Condition code
Metabolic and Endocrine 279388 279388 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: oral bisoprolol 2.5 mg daily for 7 days
Arm 2: oral formoterol 80 ug daily for 7 days
Arm 3: transdermal testosterone 50mg daily for 7 days
Arm 4: oral oestradiol 50ug daily for 1 cycle
Arm 5: subcutaneous growth hormone 0.5 mg daily for 7 days
Arm 6: oral prednisone 10 mg daily for 7 days

Subjects will be recruited into only one arm and the selection is based on the specific inclusion criteria for each arm and will be at the discretion of the investigator.
Intervention code [1] 283741 0
Treatment: Drugs
Comparator / control treatment
Each participant will be his/her own control. In other words, the energy and brown fat status of each participant will be compared before and after each treatment. There is no control group and each arm will be of equal weight.
Control group
Active

Outcomes
Primary outcome [1] 285976 0
Changes in brown fat activity and volume as measured by positron emission tomography
Timepoint [1] 285976 0
baseline and 7 days after treatment
Secondary outcome [1] 294879 0
Changes in energy expenditure and diet-induced thermogenesis
Timepoint [1] 294879 0
baseline and 7 days after treatment

Eligibility
Key inclusion criteria
Arms 1, 2 and 6: healthy adults 18+ years old
Arm 3: men with hypogonadism
Arm 4: postmenopausal women
Arm 5: growth hormone deficient adults
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are screened for inclusion and exclusion criteria. Each subject acts as his/her own control
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284223 0
Government body
Name [1] 284223 0
NHMRC
Country [1] 284223 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 269179 0
University
Name [1] 269179 0
University of Queensland
Address [1] 269179 0
Ipswich Road
Woolloongabba
QLD 4102
Country [1] 269179 0
Australia
Other collaborator category [1] 260354 0
Hospital
Name [1] 260354 0
Princess Alexandra Hospital, Brisbane
Address [1] 260354 0
Ipswich Road
Woolloongabba
QLD 4102
Country [1] 260354 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286186 0
The Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 286186 0
Centres for Health Research Level 2, Building 35 Princess Alexandra Hospital Ispwich Road WOOLLOONGABBA QLD 4102
Ethics committee country [1] 286186 0
Australia
Date submitted for ethics approval [1] 286186 0
10/10/2011
Approval date [1] 286186 0
18/11/2011
Ethics approval number [1] 286186 0
HREC/11/QPAH/569

Summary
Brief summary
The proposed study investigates the physiology of brown fat in adult humans. Brown fat plays a major role in metabolism,
protecting animals from obesity. In humans, brown fat is thought to disappear after infancy. However, metabolic imaging by positron emission tomography (PET)-CT using fluorodeoxyglucose (FDG), a glucose analogue, has revealed fat of high metabolic activity in the neck region in adults, confirmed to be brown fat on histology.

Our previous molecular and histological analysis suggests brown fat to be present in the majority of adult humans. However, factors regulating brown fat activity/abundance are unknown. By PET, brown fat prevalence was higher in women, associated with lower age, weight and glucose level, suggesting regulation by hormones and a role in energy homeostasis.

The hypothesis of the current study is that brown fat is regulated hormonally and contributes significantly to metabolism.

We aim to determine physiologic factors which regulate brown fat activity and its metabolic significance in adulthood. The
proposal involves regulatory studies in-vivo (FDG uptake) to explore effects of adrenergic, sex and metabolic hormones on brown fat activity. Metabolic significance will be determined by relating FDG uptake to diet-induced thermogenesis.
Trial website
Trial related presentations / publications
Lee P, Swarbrick MM, Zhao JT, Ho KK. Inducible brown adipogenesis in supraclavicular fat in adult humans. Endocrinology. 2011 Oct;152(10):3597-602. Epub 2011 Jul 26.

Lee P, Zhao JT, Swarbrick MM, Bova R, Gracie G, Freund J, Greenfield JR, Ho KK. High prevalence of brown adipose tissue in adult humans. J Clin Endocrinol Metab. 2011 Aug;96(8):2450-5. Epub 2011 May 25.

Lee P, Greenfield JR, Ho KK. Hot Fat in a cool man: infrared thermography and brown adipose tissue. Diabetes Obes Metab. 2011; 13: 92-3.

Lee P, Greenfield JR, Ho KK, Fulham MJ. A critical appraisal of the prevalence and metabolic significance of brown adipose tissue in adult humans. Am J Physiol Endocrinol Metab. 2010; 299: E601-6.

Lee P, Ho KKY, Fulham MJ. The importance of brown adipose tissue. N Engl J Med. 2009 23; 361:418.
Public notes

Contacts
Principal investigator
Name 33405 0
Address 33405 0
Country 33405 0
Phone 33405 0
Fax 33405 0
Email 33405 0
Contact person for public queries
Name 16652 0
Dr Paul Lee
Address 16652 0
School of Medicine
University of Queensland
Building 33
Princess Alexandra Hospital
Ipswich Road, Woolloongabba, Brisbane
QLD 4102
Country 16652 0
Australia
Phone 16652 0
61-7-3176-7097
Fax 16652 0
61-7-3176-2973
Email 16652 0
pcylee@gmail.com
Contact person for scientific queries
Name 7580 0
Dr Paul Lee
Address 7580 0
School of Medicine
University of Queensland
Building 33
Princess Alexandra Hospital
Ipswich Road, Woolloongabba, Brisbane
QLD 4102
Country 7580 0
Australia
Phone 7580 0
61-7-3176-7097
Fax 7580 0
61-7-3176-2973
Email 7580 0
pcylee@gmail.com

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.