Trial Review

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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
30/06/2024
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) 8-wk Waitlist Control (standard care 150 min/wk, exercise at any time) followed by randomised interventions; or 2) daily Exercise at peak hyperglycaemia (identified individually from CGM data); 3) daily 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
Waitlist control period 8-wk 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). Then randomised to 8wk interventions and then 3 mth follow up.
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 a Mixed Meal Tolerance Test
Timepoint [10] 372428 0
Pre-intervention, Post-intervention & 3-mth follow up
Secondary outcome [11] 406407 0
24 h glucose (including iAUC, AUC, mean) using continuous glucose monitoring
Timepoint [11] 406407 0
pre-intervention post-intervention and at 3 mo follow up
Secondary outcome [12] 406408 0
24 h glucose (including mean, maximum, minimum, AUC, iAUC) using continuous glucose monitoring
Timepoint [12] 406408 0
Pre-intervention, Mid-intervention, Post-intervention & 3-mth follow-up
Secondary outcome [13] 406409 0
24h and 3h postprandial glucose from continuous glucose monitoring (mean, maximum, minimum, AUC, iAUC)
Timepoint [13] 406409 0
Pre-intervention, Mid-intervention, Post-intervention & 3-mth follow-up
Secondary outcome [14] 406410 0
Glycaemic variability (including MAGE, SD, CONGA assessed via EasyGV platform) using continuous glucose monitoring
Timepoint [14] 406410 0
Pre-intervention, Mid-intervention, Post-intervention & 3-mth follow-up
Secondary outcome [15] 406411 0
Time in range (including time spent above 10mmol/L [hyperglycemia], below 4mmol/L [hypoglycemia] and between 4-10mmol/L) using continuous glucose monitoring
Timepoint [15] 406411 0
Pre-intervention, Mid-intervention, Post-intervention & 3-mth follow-up

Eligibility
Key inclusion criteria
• Type 2 Diabetes
*BMI between 27-40kg/m2
• HbA1c between 6.5-9%
• 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
75 Years
Sex
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
• 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 and insulin requirement
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
Completed
Date of first participant enrolment
Anticipated
11/09/2019
Actual
1/10/2020
Date of last participant enrolment
Anticipated
1/04/2022
Actual
1/08/2022
Date of last data collection
Anticipated
1/07/2022
Actual
8/05/2023
Sample size
Target
70
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303146 0
University
Name [1] 303146 0
University of Wollongong
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
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
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
[email protected]
Contact person for public queries
Name 94523 0
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
[email protected]
Contact person for scientific queries
Name 94524 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified, raw, line-by-line data
When will data be available (start and end dates)?
starting from 1 year following publication and available for 5 years after data collection
Available to whom?
researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
researchers who provide a methodologically sound proposal, case-by-case basis for any-type of analysis at the discretion of Primary Sponsor
How or where can data be obtained?
Dr Monique Francois [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.