Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000509864
Ethics application status
Approved
Date submitted
10/05/2012
Date registered
14/05/2012
Date last updated
2/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of mild cold exposure on heat production before and after a glucose load in overweight Australian adults with and without the metabolic syndrome.
Scientific title
Does mild cold acutely increase adaptive thermogenesis to a greater extent in those without the metabolic syndrome than those with the metabolic syndrome?
Secondary ID [1] 280389 0
Nil
Universal Trial Number (UTN)
Trial acronym
ATMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 286382 0
Condition category
Condition code
Metabolic and Endocrine 286663 286663 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will rest in bed in a purpose built insulated room called a climatic chamber, where the temperature can be set and maintained for prolonged periods. Subjects will be studied on two separate occasions with a maximum interval of 2 weeks in between measurements. On one occasion the temperature will be 20 degrees centigrade and on another it will be 25 degrees centigrade. This is a crossover study so each participant will be studied at these two temperatures in a random order, separated by a washout period of 2 weeks. On each occasion measurements will last for approximately 4 hours. After recording baseline measurements for 1.5 hours, participants will consume a 300 ml glucose drink (75 grams of glucose in flavoured distilled water) and measurements will resume for the next 2 hours.
Intervention code [1] 284798 0
Treatment: Other
Intervention code [2] 284799 0
Prevention
Comparator / control treatment
The control treatment is exposure to 25 degrees centigrade.
Control group
Active

Outcomes
Primary outcome [1] 287098 0
Resting energy expenditure before and after a glucose load. This in measured by monitoring the participants expired air, by placing a transparent canopy over their head while they rest in bed. The expired air content of oxygen and carbon dioxide is measured by a special machine called the Deltatrac II, and these values are converted to rates of energy expendiure by the principle of indirect calorimetry.
Timepoint [1] 287098 0
Measurements will be made at 30 min and 60 min after entering the chamber, followed by measurements every 30 min after the glucose load for a period of 2 hr. In total 6 measurements of 20 min each will be required.
Secondary outcome [1] 297367 0
Body temperature at rest and after a glucose load. In the ear hand held thermometers will record core body temperature. Surface temperatures of different locations of the body will be continuously monitored by using special ibuttons (the size of a 10 cent coin) that are attached to the body with special tape. These devices are not wired.
Timepoint [1] 297367 0
In the ear temperature measurements will be made at 30 min and 60 min after entering the chamber, followed by measurements every 30 min after the glucose load for a period of 2 hr. In total 6 measurements will be made. The ibuttons provide a continuous recording of surface temperature in their location.
Secondary outcome [2] 297368 0
Plasma Adiponectin at rest and after a glucose load. Adiponectin is a protein carried in blood that has beneficial effects on human metabolism. We will collect 6 ml of blood, process and freeze the sample for measurement on completion of the trial.
Timepoint [2] 297368 0
60 min after entering the chamber and 2 hr after the glucose load. In total 2 measurements.

Eligibility
Key inclusion criteria
Australians of European origin; overweight or obese with a body mass index (BMI) of greater than 25 kg/m2, weight stable within +/- 2 kg in the previous 6 months with no intention for weight loss within the next 6 months, with or without the metabolic syndrome.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fever, thyroid disease (by history); polycystic ovarian syndrome (by history); type II diabetes (by history); smoking; pregnancy; lactation; use of thermogenic agents; hormonal contraception; testosterone replacement
therapy; hormonal replacement therapy and women who are peri-menopausal.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to intervention or control condition first will be determined by a coin flip.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
unblinded to which subjects have the metabolic syndrome and which do not
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2012
Actual
3/09/2012
Date of last participant enrolment
Anticipated
30/11/2012
Actual
2/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5262 0
6020
Recruitment postcode(s) [2] 5263 0
6052
Recruitment postcode(s) [3] 5264 0
6151
Recruitment postcode(s) [4] 5265 0
6152
Recruitment postcode(s) [5] 5266 0
6153

Funding & Sponsors
Funding source category [1] 285202 0
University
Name [1] 285202 0
Curtin University
Country [1] 285202 0
Australia
Primary sponsor type
Individual
Name
Mario Soares
Address
School of Public Health
Curtin University
Kent Street
Bentley 6102
Perth, Western Australia
Australia
Country
Australia
Secondary sponsor category [1] 284076 0
Individual
Name [1] 284076 0
Tony James
Address [1] 284076 0
School of Public Health
Curtin University
Kent Street
Bentley 6102
Perth, Western Australia
Australia
Country [1] 284076 0
Australia
Other collaborator category [1] 260787 0
Individual
Name [1] 260787 0
Veronica Miller
Address [1] 260787 0
School of Public Health
Curtin University
Kent Street
Bentley 6102
Perth, Western Australia
Australia
Country [1] 260787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287202 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 287202 0
The Secretary, HREC
Office of Research and Development
PO Box U1987
Perth WA 6845
Ethics committee country [1] 287202 0
Australia
Date submitted for ethics approval [1] 287202 0
Approval date [1] 287202 0
01/05/2012
Ethics approval number [1] 287202 0
HR20/2012

Summary
Brief summary
The aim of this study is to understand how the body adapts to a mild cold temperature and whether this differs in people who have evidence of the following metabolic abnormalities: a large waist circumference, high blood fats, low "good" cholesterol, high blood pressure and high blood glucose levels. We believe that those who have these abnormalities will not be able to adapt as well to a cold temperature than those without the adnormalities. This will be detected by us as a smaller rise in metabolic rate and the healthy blood protein adiponectin, both before and after a simple meal, like glucose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34108 0
A/Prof Mario Soares
Address 34108 0
School of Public Health Curtin University Kent street Bentley 6102 Perth, Western Australia Australia
Country 34108 0
Australia
Phone 34108 0
+ 61 8 92663220
Fax 34108 0
+ 61 8 92662958
Email 34108 0
m.soares@curtin.edu.au
Contact person for public queries
Name 17355 0
Ms Emily Calton
Address 17355 0
School of Public Health
Curtin University
Kent street
Bentley 6102
Perth, Western Australia
Australia
Country 17355 0
Australia
Phone 17355 0
+61-401093802 (mobile)
Fax 17355 0
Email 17355 0
emily.calton@curtin.edu.au
Contact person for scientific queries
Name 8283 0
A/Prof Mario Soares
Address 8283 0
School of Public Health
Curtin University
Kent street
Bentley 6102
Perth, Western Australia
Australia
Country 8283 0
Australia
Phone 8283 0
+61 8 92663220
Fax 8283 0
+61 8 92662958
Email 8283 0
m.soares@curtin.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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