Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000918426
Ethics application status
Approved
Date submitted
5/07/2016
Date registered
11/07/2016
Date last updated
18/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of energy distribution across three main daily meals on the regulation of blood glucose during prolonged sitting compared to prolonged sitting with frequent active breaks
Scientific title
Effects of energy distribution and frequent active breaks from sitting on postprandial glycaemic control in pre-diabetic and type 2 diabetic overweight/obese older adults
Secondary ID [1] 289593 0
None
Universal Trial Number (UTN)
U1111-1184-9397
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 299360 0
Overweight/obesity 299361 0
Condition category
Condition code
Diet and Nutrition 299348 299348 0 0
Obesity
Metabolic and Endocrine 299349 299349 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete 4 x 36 h periods of activity (using ActivPal and ActiGraph monitors) and glucose (using continuous blood glucose monitors) monitoring.
Participants will spend one day at the laboratory (between 7.30 am and 7 pm) during each of the 36 h periods.

Prior to the trial day, participants will receive a standardised meal to take home and consume for their last meal of the day, have finger prick blood samples taken, have a continuous blood glucose monitor (CGM) inserted subcutaneously on their lower back and have an ActivPal activity monitor adhered to their thigh. This appointment will take ~1 h prior to trial day.

On a trial day, participants will get a taxi (costs covered by the study) to the laboratory. An indwelling cannula will be inserted into an anticubital vein of the forearm, and the study involves having serial blood measures and answering appetite questionnaires for the duration of a day (8 am to 7 pm) whilst remaining seated. Meals will be provided for breakfast (9am), lunch (1 pm) and dinner (5 pm) to consume at the laboratory.
At the end of the trial day, participants will be taxied home, and they will wear the CGM and the Activpal and ActiGraph until 8 am the next morning.
Trials will be separated by at least a 7 day period.

Condition A: Energy intake is distributed with 20% of energy at breakfast, 30% of energy at lunch and 50% of energy at dinner whilst prolonged sitting.
Condition B: Energy intake is distributed with 50% of energy at breakfast, 30% of energy at lunch and 20% of energy at dinner whilst prolonged sitting.
Condition C: Energy intake is distributed with 20% of energy at breakfast, 30% of energy at lunch and 50% of energy at dinner with frequent active breaks (2 min every 30 min) throughout the prolonged sitting period.
Condition D: Energy intake is distributed with 50% of energy at breakfast, 30% of energy at lunch and 20% of energy at dinner with frequent active breaks (2 min every 30 min) throughout the prolonged sitting period.

For both dietary interventions the macronutrient distribution will be the same (i.e. 50% energy from carbohydrate, 20% energy from protein and 30% energy from fat)..

Participants will complete food and activity diaries across the period encompassing the day prior to and the day after each trial day to ensure adherence. Whilst in the laboratory, participants will be monitored by the research staff.
Intervention code [1] 295198 0
Other interventions
Comparator / control treatment
The participants act as their own control (where Condition A is the control condition) and complete all four conditions
Control group
Active

Outcomes
Primary outcome [1] 298850 0
Change in blood glucose area under the curve using subcutaneous blood glucose monitors, validated with serial finger prick samples.
Timepoint [1] 298850 0
Pre to post intervention (i.e. from insertion the night before trial day to 8 am on the day after trial day) with finger prick samples at 1 h post insertion (i.e. 5 pm of the day before), prior to sleep (day before), prior to breakfast, prior to lunch, prior to dinner, prior to sleep (trial day) and the morning after the trial.
Secondary outcome [1] 325430 0
Changes in measures of appetite measured through ratings of perceived levels of hunger and satiety (“fullness”) and measures of fatigue measured through ratings of perceived levels of energy and alertness. Appetite and fatigue scores will be assessed using 100-mm visual analogue scales (VAS) on a computer based program on a laptop. Subjects will be asked to mark their perceived hunger rating on a 0 to 100 likert scale (from not at all hungry to very hungry) to indicate their feelings at that time-point.
Timepoint [1] 325430 0
These will be measured before and every 60 min after breakfast, lunch and dinner.
Secondary outcome [2] 325431 0
Plasma triglyceride response
Timepoint [2] 325431 0
Measured hourly across the 10 hour laboratory period using a Cobas c 101 analyser
Secondary outcome [3] 325432 0
Plasma insulin response
Timepoint [3] 325432 0
Measured hourly across the 10 hour laboratory period and batch analysed using plasma samples (that will be stored at -80 degrees Celsius until analysis) using a multiplex bead assay.
Secondary outcome [4] 325433 0
Sleep quality
Timepoint [4] 325433 0
Assessed prior to the intervention (3 nights) and each trial intervention night, using a sleep questionnaire and with participants wearing an accelerometer device.
Secondary outcome [5] 325443 0
Appetite hormones (ghrelin, leptin)
Timepoint [5] 325443 0
Measured hourly across the 10 hour laboratory period and batch analysed using plasma samples (that will be stored at -80 degrees Celsius until analysis) using a multiplex bead assay.
Secondary outcome [6] 325444 0
Metabolic hormones (GLP-1, c-peptide)
Timepoint [6] 325444 0
Measured hourly across the 10 hour laboratory period and batch analysed using plasma samples (that will be stored at -80 degrees Celsius until analysis) using a multiplex bead assay.

Eligibility
Key inclusion criteria
Presenting as pre-diabetic - [by having a fasting blood glucose greater than 5.9 mmol/L and/or a 2 hour oral glucose tolerance test blood glucose between 7.8 mmol/L and 11.0 mmol/L] OR as Type 2 diabetic - [by having a fasting blood glucose greater than 7.2 mmol/L and/or a 2 hour oral glucose tolerance test blood glucose greater than 11.0 mmol/L.
Being overweight or obese - [body mass index (BMI) greater than 25 kg/m2 and less than 45 kg/m2.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded on the basis of: pregnancy; use of carbohydrate or lipid-lowering medication if it has been commenced within 3 months; bariatric surgery (gastric bypass or banding); employment in a non-sedentary occupation; currently watching less than 3 hours of television or computer use per day; regularly engaged in moderate-intensity exercise for greater than 150 min/week for more than 3 months; major illness/injury (acute or chronic), current smoker or use of nicotine replacement therapy; or physical or major illness/physical problems (acute or chronic) that may limit their ability to participate in the intervention.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer-generated, randomised sequence. An independent third party will prepare the computer-generated randomisation lists and sealed envelopes for randomisation. Once informed consent is obtained, the sealed randomisation envelope will be opened revealing the trial-condition order.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Latin Square
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalized linear mixed models (GLMMs) will be used to evaluate the differential effects of the experimental conditions on the outcomes. GLMMs are appropriate for correlated data (repeated measures) with various distributional assumptions and can easily accommodate missing data. A significance level of 0.05 will be adopted.

Power calculations have been made in relation to the primary outcome measures of postprandial glucose (daily CGM and venous collections). Based on our own data (Larsen et al., Clin Sci (Lond), 2015) and previously published work (Jakubowicz et al., Obesity (Silver Spring), 2013), we have estimated that a sample size of 22 is needed to detect a between treatment difference of 0.9mmol/L with a minimum power of 80% and a probability of 0.05 (2-tailed test). This is based on the assumption that the within-patient standard deviation of the response variable (blood glucose) is 1.04. As a safeguard and using our experience from previous behavioural interventions, we will over-sample to cover an estimated attrition rate of 15%. Thus, 25 participants will be recruited.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
19/02/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13566 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 294000 0
Charities/Societies/Foundations
Name [1] 294000 0
Novo-Nordisk Foundation
Country [1] 294000 0
Sweden
Primary sponsor type
Individual
Name
Professor John Hawley
Address
Level 5, 215 Spring Street
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000 VIC
Country
Australia
Secondary sponsor category [1] 292820 0
Individual
Name [1] 292820 0
Professor David Dunstan
Address [1] 292820 0
Baker IDI Heart and Diabetes Institute
PO Box 6492, Melbourne
Victoria 3004, Australia
Country [1] 292820 0
Australia
Other collaborator category [1] 279062 0
Individual
Name [1] 279062 0
Dr Evelyn Parr
Address [1] 279062 0
Level 5, 215 Spring Street
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000 VIC
Country [1] 279062 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295411 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 295411 0
Ethics committee country [1] 295411 0
Australia
Date submitted for ethics approval [1] 295411 0
21/04/2016
Approval date [1] 295411 0
05/07/2016
Ethics approval number [1] 295411 0
2016-107H

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

Contacts
Principal investigator
Name 67122 0
Prof John Hawley
Address 67122 0
Level 5, 215 Spring Street
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000 VIC
Country 67122 0
Australia
Phone 67122 0
+61399533552
Fax 67122 0
Email 67122 0
[email protected]
Contact person for public queries
Name 67123 0
Evelyn Parr
Address 67123 0
Level 5, 215 Spring Street
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000 VIC
Country 67123 0
Australia
Phone 67123 0
+61413477697
Fax 67123 0
Email 67123 0
[email protected]
Contact person for scientific queries
Name 67124 0
John Hawley
Address 67124 0
Level 5, 215 Spring Street
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000 VIC
Country 67124 0
Australia
Phone 67124 0
+61399533552
Fax 67124 0
Email 67124 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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