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Trial registered on ANZCTR


Registration number
ACTRN12615000084583
Ethics application status
Approved
Date submitted
13/01/2015
Date registered
2/02/2015
Date last updated
2/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of mild changes in temperature on metabolic rates before and after a glucose load: a study of European Australians
Scientific title
The influence of mild cold on basal and postprandial thermogenesis: a study of overweight and obese Australians of European origin
Secondary ID [1] 283093 0
nil known
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 294042 0
Condition category
Condition code
Diet and Nutrition 290301 290301 0 0
Obesity
Metabolic and Endocrine 294344 294344 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be studied in a purpose built room where the temperature is regulated. The chamber is housed within a large room of the institute. Participants will be studied on three occasions during a total of 4 hours exposure to 20 degrees C or 25 degrees C or 27 degrees C in random order. A minimum of washout of one week will apply between trials.
Participants with known impaired glucose tolerance or Type 2 Diabetes must have been diagnosed for at least 2 years and have their condition well controlled. Participants should have residing in Australia for more than 2 years. We will measure metabolic rate, endothelial function, blood pressure, skin temperature, fat and carbohydrate oxidation at rest. Following a fasting blood sample collection after 1.5 hour exposure to selected temperature, participants will ingest a glucose solution (75 g in 300 ml water, OGTT). All measurements will be continued at each half hour after glucose for a further 2 hours. Participants will be required to lie in bed, reading or listening to music in between measurements. A final blood sample for lipids, insulin glucose and liver function tests will be made 2 hours after the glucose drink and conclude the trial.
Intervention code [1] 287809 0
Early detection / Screening
Intervention code [2] 287810 0
Lifestyle
Comparator / control treatment
Thermoneutral temperature of 27 degrees
Control group
Active

Outcomes
Primary outcome [1] 290334 0
Basal metabolic rate is measured through a canopy based indirect calorimetry system (Deltatrac II, Datex Finland).
Timepoint [1] 290334 0
Measured from 1 hr to 1.5 hr after exposure to selected temperature in fasting state.
Primary outcome [2] 290335 0
Glucose induced thermogenesis is calculated as the increment in metabolic rate following glucose.
Timepoint [2] 290335 0
Area under 2 hr post ingestion curve from serial measures of indirect calorimetry after glucose ingestion.
Primary outcome [3] 290336 0
Forearm to finger tip temperature gradient is measured by placing two temperature sensors (ibuttons) on the forearm and digit of one finger of the same hand.
Timepoint [3] 290336 0
Measured from 1 - 1.5 hr after exposure to temperature at fasting and over the entire 2 hour postprandial period following glucose.
Secondary outcome [1] 304323 0
In the ear temperature from tympanic thermometer (Omron, Japan)
Timepoint [1] 304323 0
measurements at 1.5 hr fasting and serially every 30 min following glucose drink.
Secondary outcome [2] 312603 0
systolic and diastolic blood pressure from semi-automated blood pressure instrument (Omron, Japan)
Timepoint [2] 312603 0
measurements at fasting and serially every 30 min following glucose for 2 hours.
Secondary outcome [3] 312604 0
endothelial function from non-invasive digital photoplethysmography (Pulse Trace, UK)
Timepoint [3] 312604 0
measurements at fasting and serially every 30 min following glucose for 2 hours.
Secondary outcome [4] 312605 0
triglycerides from plasma using Architect c16000 analyser and specific enzyme-based colorimetric reagents.
Timepoint [4] 312605 0
measurements at fasting and at 2 hour following glucose drink.
Secondary outcome [5] 312606 0
Irisin from plasma using specific ELISA kit (AdipoGen).
Timepoint [5] 312606 0
measured at fasting and 2 hour following glucose drink.
Secondary outcome [6] 312607 0
Fibroblast growth factor 21 from plasma using specific ELISA kit (AdipoGen).
Timepoint [6] 312607 0
measured at fasting and 2 hours following glucose drink
Secondary outcome [7] 312608 0
insulin from blood sample using Architect i2000SR Analyser (Abbott Diagnostics).
Timepoint [7] 312608 0
measurements at fasting and at 2 hours following glucose drink.
Secondary outcome [8] 312609 0
glucose from blood sample based on specific glucose kit (Architect analyser).
Timepoint [8] 312609 0
measured at fasting and at 2 hours following glucose drink.

Eligibility
Key inclusion criteria
Australians of European origin who have resided in Perth for at least 2 years, age range of 20–70 years; overweight or obese (Fat % over 25), weight stable (< +/- 2 kg) in the previous 6 months with no intention for losing weight in the next 6 months; absence of thyroid disease (by history); absence of polycystic ovarian syndrome (by history); non-smokers; non-pregnant, non-lactating; not on hormonal contraception or testosterone replacement therapy or hormonal replacement therapy. Type 2 diabetics on good glucose control as judged by HbA1c <5.4 mmol/L (7%) will be included. Screened participants, will then be provided with the Participant Information sheet.
Minimum age
20 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
smokers; pregnant, lactating; on hormonal contraception or testosterone replacement therapy or hormonal replacement therapy, diabetics with poor glucose control, any history of cancer, heart attacks, thyroid conditions

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants will be recruited if they fulfill all inclusion and exclusion criteria. They will then be asked to sign an informed consent form. All participants will be exposed to all three temperatures on three separate days. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participants will be exposed to all three temperatures in a randomised manner. The first exposure is decided by a computer generated system using random allocation software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To calculate the effect size we used a 3% variance in BMR on cold exposure and a within subject error variance of 13% (GPower version 3.1.9.2). Hence for an effect size of 0.480, a power of 0.95, alpha = 0.05 and an MANOVA for repeated measures, we can detect differences in treatment (3 temperatures,), if we recruit 18 participants. We will recruit 10% more to allow for dropouts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7294 0
6845 - Perth

Funding & Sponsors
Funding source category [1] 287858 0
University
Name [1] 287858 0
School of Public Health, Curtin University
Address [1] 287858 0
Bentley Campus, Kent Street,
Perth 6845 WA
Country [1] 287858 0
Australia
Primary sponsor type
Individual
Name
Mario Soares
Address
Curtin University Bentley Campus,
School of Public Health,
Kent Street,
Perth 6845 WA
Country
Australia
Secondary sponsor category [1] 286587 0
None
Name [1] 286587 0
none
Address [1] 286587 0
Nil
Country [1] 286587 0
Other collaborator category [1] 278289 0
Individual
Name [1] 278289 0
Anthony James
Address [1] 278289 0
Curtin University Bentley Campus,
School of Public Health,
Kent Street,
Perth 6845 WA
Country [1] 278289 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289801 0
Human Research Ethics Committee
Ethics committee address [1] 289801 0
Bentley Campus, Kent Street,
Perth 6845 WA
Ethics committee country [1] 289801 0
Australia
Date submitted for ethics approval [1] 289801 0
24/06/2012
Approval date [1] 289801 0
08/10/2012
Ethics approval number [1] 289801 0
HR 103/2012

Summary
Brief summary
The aim of the study is to understand how the body’s metabolism changes in response to mild cold. In general, people with obesity, insulin resistance or diabetes do not increase their metabolic rate as much as those who are insulin sensitive.
Trial website
Trial related presentations / publications
Pathak K, James AP & Soares MJ. Thermogenic responses to mild cold exposure in overweight and obese individuals. Annual meeting of Nutrition Society of Australia 26-28th Nov 2014. Hobart Tasmania.
Public notes

Contacts
Principal investigator
Name 42422 0
A/Prof Mario Soares
Address 42422 0
School of Public Health,
Curtin University, Bentley Campus
Kent Street, Perth WA 6845
Country 42422 0
Australia
Phone 42422 0
+ 61 8 92663220
Fax 42422 0
+ 61 8 92662958
Email 42422 0
m.soares@curtin.edu.au
Contact person for public queries
Name 42423 0
Ms Kaveri Pathak
Address 42423 0
School of Public Health,
Curtin University, Bentley Campus
Kent Street, Perth WA 6845
Country 42423 0
Australia
Phone 42423 0
+ 61 402176445
Fax 42423 0
Email 42423 0
kaveri.pathak@postgrad.curtin.edu.au
Contact person for scientific queries
Name 42424 0
A/Prof Mario Soares
Address 42424 0
School of Public Health,
Curtin University, Bentley Campus
Kent Street, Perth WA 6845
Country 42424 0
Australia
Phone 42424 0
+ 61 8 92663220
Fax 42424 0
+ 61 8 92662958
Email 42424 0
m.soares@curtin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary