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Trial registered on ANZCTR


Registration number
ACTRN12614000222640
Ethics application status
Approved
Date submitted
20/02/2014
Date registered
3/03/2014
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Date results provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognition and Type 2 Diabetes – A pilot randomised controlled trial (RCT) of exercise
Scientific title
In people with type 2 diabetes, does structured exercise improve or preserve brain health?
Secondary ID [1] 284130 0
Nil
Universal Trial Number (UTN)
U1111-1153-6018
Trial acronym
CDOT-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive impairment 291209 0
dementia 291210 0
type 2 diabetes 291211 0
Condition category
Condition code
Neurological 291545 291545 0 0
Dementias
Physical Medicine / Rehabilitation 291546 291546 0 0
Other physical medicine / rehabilitation
Metabolic and Endocrine 291608 291608 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a 6 month structured exercise program by fully trained exercise physiologists. Two one-hour supervised sessions per week will occur at the Menzies Research Institute gymnasium on non-consecutive days, plus a further one-hour per week unsupervised session at the participant’s home with prescribed exercises (e.g. walking). Each supervised session will consist of a warm-up and cool-down, moderate- to high-intensity progressive resistance training exercises using body weight, simple machine or free weights of 8-15 repetitions (e.g. free weights: bicep curls, shoulder press, chest press; body weight: step ups or sit to stand +/- weight vest; machine weights: quadriceps press, shoulder press, chest press, knee extension), and an aerobic component involving stationary cycling, cross trainer or treadmill walking at 40-84% of VO2R. The program will be tailored to participant’s abilities and progressive intensity applied with increasing fitness. Adherence will be assessed by attendance at the supervised exercise sessions and completion of personal exercise diaries.
Intervention code [1] 288821 0
Treatment: Other
Intervention code [2] 288822 0
Lifestyle
Comparator / control treatment
The control arm will also receive a 6 month light stretching/gentle movements program. Two one-hour supervised sessions per week will occur at the Menzies Research Institute, and the participants will be asked to carry out one unsupervised session at home. Each session will consist of gentle stretches and movements of the upper and lower limb muscles. Adherence will be assessed by attendance at the supervised exercise sessions and completion of personal exercise diaries.
Control group
Active

Outcomes
Primary outcome [1] 291511 0
Brain MRI - grey matter volume
Timepoint [1] 291511 0
baseline and 6 months
Secondary outcome [1] 306933 0
Brain MRI – Measures of interest are brain volumes (white, white matter lesion, hippocampus), regional cerebral perfusion (CBF using arterial spin labeling ASL), white matter integrity (fractional anisotropy FA, mean diffusivity MD using diffusion tensor imaging DTI).
Timepoint [1] 306933 0
Baseline and 6 months
Secondary outcome [2] 306934 0
Cognitive measures: assessments of selective attention, executive function, processing speed and memory will be made using standard neurological tests:Hopkins Verbal Learning Test – R, Form 1; Wechsler Adult Intelligence Scale – Third Edition (WAIS-III) Subsets of Digit Span, Digit Symbol Coding and Symbol Search; Controlled Oral Word Association Test (COWAT); Category Fluency Test; Rey Complex Figure copying and delayed recall task; Stroop Test (Victoria Form);Trails A & B.
Timepoint [2] 306934 0
Baseline and 6 months
Secondary outcome [3] 306935 0
Central haemodynamics: These will be measured non-invasively at rest, during exercise VO2 test and over 24 hours
Timepoint [3] 306935 0
Secondary outcome [4] 306936 0
Retinal photography using a Canon CR-DGi non-mydriatic retinal camera– retinal vascular measures (length/diameter, optimality ratio)
Timepoint [4] 306936 0
Baseline and 6 months
Secondary outcome [5] 306937 0
Short Physical Performance Battery
Timepoint [5] 306937 0
Baseline and 6 months
Secondary outcome [6] 309709 0
Skin microvessel function measured by Laser Doppler Flowmetry
Timepoint [6] 309709 0
Baseline and 6 months
Secondary outcome [7] 309710 0
Echocardiogram to measure left heart function
Timepoint [7] 309710 0
Baseline and 6 months
Secondary outcome [8] 309711 0
Fasting bloods – for fasting glucose, insulin, lipids, HbA1C and stored at -80 for future assays of, neurotrophins, serum AGEs plasma cytokine and oxidative stress markers
Timepoint [8] 309711 0
Baseline and 6 months
Secondary outcome [9] 309712 0
Usual physical activity measured with accelerometers worn over 7 days (measured at baseline, 3months and in the last week of the intervention or control program);
Timepoint [9] 309712 0
Baseline, 3 months and last week of the intervention
Secondary outcome [10] 309713 0
Urine sample to measure albuminuria.
Timepoint [10] 309713 0
Baseline - before and after VO2max test
6 month follow-up before and after VO2max test
Secondary outcome [11] 309714 0
Aerobic capacity: VO2max using a treadmill(Bruce or Modified Bruce test)
Timepoint [11] 309714 0
Baseline and 6 months
Secondary outcome [12] 309715 0
Knee strength with the short form of the Physiological Profile Assessment
Grip strength with a hand dynamometer
Timepoint [12] 309715 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Inclusion criteria
1) T2DM as diagnosed by fasting blood glucose greater or equal to 7 mmol/L or HbA1C greater than 6.4 % or 2 hr post-prandial glucose greater than 11 mmol/L according to current American Diabetes Association Guidelines.
2) Age 50-75 years
3) Be willing and able to participate in a structured exercise program for 6-months.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1) any severe medical condition that precludes safe participation in exercise;
2) moderate or severe dementia
3)Known central nervous system disorders that may have confounding effects on cognitive function (e.g. tumour, multiple sclerosis, Parkinsons disease)
4)contra-indication to MRI;
5) exercising greater than the equivalent of 30 minutes once a week in the last 3 months.

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)
Randomised by central automated allocation procedure based on computer-generated random numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomized within two age strata of 50-65 years and 65-75 years with equal allocation between strata and random block sizes within strata
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An important aim of this pilot study is to obtain preliminary data on which to base sample size estimates for the main study. The distributions of outcome and study factors will be summarised by means and standard deviations for continuous variables, and by frequencies and percentages for categorical variables. The efficacy analyses will be undertaken as planned in the main study but only for the purpose of estimating change and variability of change in the outcome measures. They will be performed on an intention-to-treat basis, and both without and with multiple imputation of missing data. In addition, we will perform per-protocol analyses of those participants who meet the criterion of at least 70% adherence to their exercise prescription. Adverse event data will be summarised and presented by treatment group and time point in summary tables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2014
Actual
26/06/2014
Date of last participant enrolment
Anticipated
Actual
13/05/2015
Date of last data collection
Anticipated
Actual
20/12/2015
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 288762 0
Charities/Societies/Foundations
Name [1] 288762 0
Alzheimers Australia Dementia Research Foundation Grant
Country [1] 288762 0
Australia
Primary sponsor type
Individual
Name
Dr Michele Callisaya
Address
Stroke and Ageing Research Group
Southern Clinical School, Monash University
Level 5 E Block Monash Medical Centre 246 Clayton Road, Clayton Victoria 3168
Country
Australia
Secondary sponsor category [1] 287459 0
Individual
Name [1] 287459 0
Associate Professor Velandai Srikanth
Address [1] 287459 0
Stroke and Ageing Research Group
Southern Clinical School, Monash University
Level 5 E Block, Monash Medical Centre 246 Clayton Road, Clayton Victoria 3168
Country [1] 287459 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290600 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 290600 0
Ethics committee country [1] 290600 0
Australia
Date submitted for ethics approval [1] 290600 0
Approval date [1] 290600 0
21/01/2014
Ethics approval number [1] 290600 0
H13664
Ethics committee name [2] 290601 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [2] 290601 0
Ethics committee country [2] 290601 0
Australia
Date submitted for ethics approval [2] 290601 0
Approval date [2] 290601 0
04/02/2014
Ethics approval number [2] 290601 0
2014-012
Ethics committee name [3] 290602 0
Monash University Human Research Ethics Committee
Ethics committee address [3] 290602 0
Ethics committee country [3] 290602 0
Australia
Date submitted for ethics approval [3] 290602 0
Approval date [3] 290602 0
03/02/2014
Ethics approval number [3] 290602 0
CF14/281-201400009
Ethics committee name [4] 290603 0
Human Research Ethics Office of The University of Western Australia
Ethics committee address [4] 290603 0
Ethics committee country [4] 290603 0
Australia
Date submitted for ethics approval [4] 290603 0
Approval date [4] 290603 0
24/01/2014
Ethics approval number [4] 290603 0
RA/4/1/6611

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

Contacts
Principal investigator
Name 46394 0
Dr Michele Callisaya
Address 46394 0
Stroke and Ageing Research Group
Southern Clinical School
Level 5 E Block,
Monash Medical Centre Monash Univeristy
246 Clayton Road, Clayton Victoria 3168
Country 46394 0
Australia
Phone 46394 0
+61 3 62264785
Fax 46394 0
Email 46394 0
michele.callisaya@monash.edu
Contact person for public queries
Name 46395 0
Michele Callisaya
Address 46395 0
Stroke and Ageing Research Group
Southern Clinical School
Level 5 E Block,
Monash Medical Centre Monash Univeristy
246 Clayton Road, Clayton Victoria 3168
Country 46395 0
Australia
Phone 46395 0
+61 3 62264785
Fax 46395 0
Email 46395 0
michele.callisaya@monash.edu
Contact person for scientific queries
Name 46396 0
Michele Callisaya
Address 46396 0
Stroke and Ageing Research Group
Southern Clinical School
Level 5 E Block,
Monash Medical Centre Monash Univeristy
246 Clayton Road, Clayton Victoria 3168
Country 46396 0
Australia
Phone 46396 0
+61 3 62264785
Fax 46396 0
Email 46396 0
michele.callisaya@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected during the trial
When will data be available (start and end dates)?
now for 5 years
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?
Those that meet the aims of the approved proposal
How or where can data be obtained?
Request to CI and via signing a data sharing agreement


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
SourceTitleYear of PublicationDOI
EmbaseFeasibility of a multi-modal exercise program on cognition in older adults with Type 2 diabetes - a pilot randomised controlled trial.2017https://dx.doi.org/10.1186/s12877-017-0635-9
N.B. These documents automatically identified may not have been verified by the study sponsor.