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Trial registered on ANZCTR


Registration number
ACTRN12619001049167
Ethics application status
Approved
Date submitted
30/06/2019
Date registered
25/07/2019
Date last updated
9/09/2019
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The best time to exercise for people with type 2 diabetes
Scientific title
Preventing Cardiovascular Disease in people with Type 2 Diabetes: When is the Right Time to Move?
Secondary ID [1] 298628 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 313500 0
Condition category
Condition code
Metabolic and Endocrine 311928 311928 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with Type 2 Diabetes will be advised to engage in moderate intensity walking (Borg RPE 11-13) physical activity every day for 5 months (~150 min/week, ~22 min/day). Participants will be randomised to 1 of 3 groups; 1) Control standard care (exercise at any time); 2) Exercise at peak hyperglycemia (identified individually from CGM data); 3) Exercise not at peak (identified individually from CGM data. The intervention period is 8 weeks, 5 sessions are supervised by an Accredited Exercise Physiologist and the majority of sessions performed at home unsupervised. Adherence will be assessed using accelerometry mid 8-wk intervention, post 8-wk intervention and after a 3 month free living period where participants will be asked to continue their prescribed exercise intervention independently and without contact.
Intervention code [1] 314892 0
Lifestyle
Comparator / control treatment
Standard care advice pertaining to the current Australian Physical Activity & Sedentary Behaviour Guidelines (accumulate 150 min of light to moderate intensity physical activity each wk).
Control group
Active

Outcomes
Primary outcome [1] 320593 0
HbA1c from fasting blood sample
Timepoint [1] 320593 0
Baseline, Post Intervention [primary timepoint] & 3-month follow up.
Secondary outcome [1] 372144 0
Endothelial Function assessed by Flow-Mediated Dilation (noninvasive ultrasound).
Timepoint [1] 372144 0
Baseline, Post Intervention & 3-month follow up.
Secondary outcome [2] 372145 0
Blood Pressure assessed using 24-h ambulatory BP monitoring
Timepoint [2] 372145 0
Baseline, Post Intervention & 3-month follow up.
Secondary outcome [3] 372146 0
Arterial Stiffness assessed using pulse wave velocity (Sphygmocor Xcel)
Timepoint [3] 372146 0
Baseline, Post Intervention & 3-month follow up.
Secondary outcome [4] 372147 0
Triglycerides fasting blood sample
Timepoint [4] 372147 0
Baseline, Post Intervention & 3-month follow up.
Secondary outcome [5] 372148 0
C-reactive protein from fasting blood sample
Timepoint [5] 372148 0
Baseline, Post Intervention & 3-month follow up.
Secondary outcome [6] 372149 0
Exercise adherence assessed by accelerometers
Timepoint [6] 372149 0
Assessed for 7 days at baseline, mid-intervention, final week of intervention & 3-months post.
Secondary outcome [7] 372232 0
HDL from fasting blood sample
Timepoint [7] 372232 0
Pre-intervention, Post-intervention & 3-mth follow up
Secondary outcome [8] 372233 0
LDL from fasting blood sample
Timepoint [8] 372233 0
Pre-intervention, Post-intervention & 3-mth follow up
Secondary outcome [9] 372234 0
Total Cholesterol from fasting blood sample
Timepoint [9] 372234 0
Pre-intervention, Post-intervention & 3-mth follow up
Secondary outcome [10] 372428 0
Postprandial glucose (AUC) assessed from an Oral Glucose Tolerance Test
Timepoint [10] 372428 0
Pre-intervention, Post-intervention & 3-mth follow up
Secondary outcome [11] 372429 0
Postprandial insulin (AUC) assessed from an Oral Glucose Tolerance Test
Timepoint [11] 372429 0
Pre-intervention, Post-intervention & 3-mth follow up
Secondary outcome [12] 372430 0
Postprandial fatty acids assessed from an Oral Glucose Tolerance Test
Timepoint [12] 372430 0
Pre-intervention, Post-intervention & 3-mth follow up
Secondary outcome [13] 372431 0
Insulin sensitivity assessed from an Oral Glucose Tolerance Test
Timepoint [13] 372431 0
Pre-intervention, Post-intervention & 3-mth follow up

Eligibility
Key inclusion criteria
• Type 2 Diabetes <20 y BMI between 27-40kg/m2
• HbA1c between 6.5-9%
• Diabetes treated with lifestyle and/or oral medications
• Non-smoker (for >6 months prior to study start)
• Stable weight for previous 3 months (± 4kgs)
• Stable medications for previous 3 months
Minimum age
40 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Presence of any absolute contraindications to exercise (including musculoskeletal and joint)
• Known CVD or prior history of CVD
• Diabetes treated with insulin
• Uncontrolled Hypertension
• Prior history of kidney and/or liver disease
• Diagnosed Neuropathy
• >150 minutes exercise/week

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Simple randomisation computer program using Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple permuted blocked (of 6) randomisation using a randomisation table created by computer software stratified for sex
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will first be assessed for normality using Q-Q plots, histograms and the shapiro-wilk test. A Linear mixed model (with time x intervention interaction, and main effects of time) will compare the changes in study outcomes between intervention & control groups.

Recruitment
Recruitment status
Recruiting
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)
NSW

Funding & Sponsors
Funding source category [1] 303146 0
University
Name [1] 303146 0
University of Wollongong
Address [1] 303146 0
Northfields Avenue
Wollongong NSW 2500
Country [1] 303146 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue
Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 303143 0
None
Name [1] 303143 0
Address [1] 303143 0
Country [1] 303143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303695 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 303695 0
Northfields Avenue
Wollongong NSW 2500
Ethics committee country [1] 303695 0
Australia
Date submitted for ethics approval [1] 303695 0
16/04/2019
Approval date [1] 303695 0
13/06/2019
Ethics approval number [1] 303695 0
2019/ETH09856

Summary
Brief summary
This project seeks to determine the feasibility and effectiveness of timing exercise to control blood glucose levels and reduce cardiovascular risk in people with Type 2 Diabetes. People with Type 2 Diabetes will be randomised to standard care alone or with time of exercise specified to coincide with/avoid blood glucose peak. It is hypothesised that individually prescribing ‘the time’ a person should exercise will optimised blood glucose control and attenuate peak blood glucose when compared to standard care and exercise at times other than peak.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94522 0
Dr Monique Francois
Address 94522 0
University of Wollongong
Faculty of Science, Medicine and Health
Northfields Avenue
Wollongong NSW 2522
Country 94522 0
Australia
Phone 94522 0
+61 242215136
Fax 94522 0
Email 94522 0
francois@uow.edu.au
Contact person for public queries
Name 94523 0
Mrs Brooke Russell
Address 94523 0
University of Wollongong
Faculty of Science, Medicine and Health
Northfields Avenue
Wollongong NSW 2522
Country 94523 0
Australia
Phone 94523 0
+61 491614340
Fax 94523 0
Email 94523 0
brooker@uow.edu.au
Contact person for scientific queries
Name 94524 0
Mrs Brooke Russell
Address 94524 0
University of Wollongong
Faculty of Science, Medicine and Health
Northfields Avenue
Wollongong NSW 2522
Country 94524 0
Australia
Phone 94524 0
+61 491614340
Fax 94524 0
Email 94524 0
brooker@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality
What supporting documents are/will be available?
No other documents available
Summary results
No Results