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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

BATTMAN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Diabetes

Condition category

Condition code

Metabolic and Endocrine

Metabolic disorders

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

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]

Glucose tolerance by standard oral glucose tolerance test.

Timepoint [1]

Conducted at time 0, 60 and 120 minutes at each visit

Secondary outcome [1]

Adipokine profile by serum assay

Timepoint [1]

At time 0, 60 and 120 minutes at each visit

Secondary outcome [2]

Brown fat quantity assessed by PET scanning

Timepoint [2]

At time 120 minutes of each visit

Secondary outcome [3]

Energy burning rate by indirect calorimetry

Timepoint [3]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Diabetes Australia Research Trust (DART) grant

Address [1]

Level 1, 101 Northbourne Avenue TURNER ACT 2612

GPO Box 3156 CANBERRA ACT 2601

Country [1]

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]

Hospital

Name [1]

St Vincent's Hospital, Sydney

Address [1]

380 Victoria Street
Darlinghurst
NSW 2010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital HREC

Ethics committee address [1]

Level 6 deLacy Building
St Vincent's Research Office
St Vincent's Hospital
380 Victoria Street
Darlinghurst NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/01/2014

Approval date [1]

11/02/2014

Ethics approval number [1]

HREC/13/SVH/377

Summary

Brief summary

Obesity is a major health issue worldwide. Despite global research efforts, effective treatments for obesity are limited. There are two kinds of fat in the body: white fat and brown fat. White fat functions mainly as an energy-storing organ and in excess results in obesity and complications such as diabetes and high blood pressure. Brown fat on the other hand releases the energy stored in fat as heat. It protects small animals and newborn human infants from cold temperatures. 

New imaging techniques have revealed brown fat to be present in significant amount in adult humans. Using special metabolic imaging, called PET scanning, brown fat is shown to be more abundant in lean individuals with lower blood glucose levels, suggesting that brown fat may regulate energy balance and metabolism. 

In animals, cold temperature and food both stimulate brown fat, resulting in release of energy. This is called adaptive thermogenesis, and it represents a considerable portion of total daily energy expenditure. Whether brown fat controls adaptive thermogenesis in humans is unclear. This is clinically relevant because if brown fat regulates adaptive thermogenesis in humans, strategies can be developed to stimulate brown fat to increase energy expenditure, which may be a new method to help attain weight control and develop treatment of obesity-related disorders.

In order to determine the physiologic significance of brown fat activation, we designed a study investigating the effects of cold exposure and food on brown fat in humans. 

We hypothesize that adaptive thermogenesis in adult humans can be activated by cold or food, and the extent depends on individual brown fat abundance. Brown fat activity can be increased by cold stimulation, which could result in beneficial metabolic changes in the body.

The aims of the current project are to:
1)	determine relationship between brown fat and adaptive thermogenesis 
2)	investigate the underlying hormonal mechanisms and significance of brown fat activation 

Brown fat abundance will first be measured by PET scanning during mild cold condition. Volunteers then undergo metabolic and hormonal testing at standard ambient temperature (24 degrees). A parallel study will examine brown fat biopsies obtained during elective neck surgery to investigate mechanisms underlying brown fat activation. 

Significance: Based on its role in energy homeostasis and protection against obesity in animals, brown fat is likely to have a similar role in adult humans. Determining the contribution of brown fat to energy metabolism may lead to novel treatment strategies of obesity.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Paul Lee

Address

Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
NSW 2010

Country

Australia

Phone

+61 2 9295 8416

Fax

+61 2 9295 8481

p.lee@garvan.org.au

Contact person for public queries

Name

Paul Lee

Address

Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
NSW 2010

Country

Australia

Phone

+61 2 9295 8416

Fax

+61 2 9295 8481

p.lee@garvan.org.au

Contact person for scientific queries

Name

Paul Lee

Address

Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
NSW 2010

Country

Australia

Phone

+61 2 9295 8416

Fax

+61 2 9295 8481

p.lee@garvan.org.au

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

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No additional documents have been identified.

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