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Trial registered on ANZCTR


Registration number
ACTRN12608000075381
Ethics application status
Approved
Date submitted
8/02/2008
Date registered
11/02/2008
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a 5 month intensive exercise program in type 1 diabetic adolescents improve cardiac and peripheral vascular function?
Scientific title
Randomised controlled trial of the effects of exercise on the cardiovascular function of type 1 diabetic adolescents
Universal Trial Number (UTN)
Trial acronym
ACE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 2803 0
Condition category
Condition code
Metabolic and Endocrine 2938 2938 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On the first visit weight, height, waist and hip circunference, blood pressure, fasting blood test, body composition (DEXA scan) and brachial ultrasound will be obtained. On the second visit participants will perform an incremental exercise test to maximal effort (VO2max test) on a stationary bicycle. On the thrid visit cardiac magnetic reasonance imaging (MRI) will be performed at rest and during bouts of steady-state submaximal exercise using a supine leg ergometer. Participants will then be randomised to an exercise or non-exercise group. The exercise intervention will consist of 20 weeks of exercise training (60 minutes, 4 times a week of combined aerobic and resistance training). After 20 weeks all participants (exercising and non-exercising) will have their initial assessments repeated.
Intervention code [1] 2542 0
Treatment: Other
Comparator / control treatment
Control group will not participate in any exercise
Control group
Active

Outcomes
Primary outcome [1] 3821 0
Aerobic Capacity assessed by VO2max test
Timepoint [1] 3821 0
at baseline and 20 weeks after randomisation
Primary outcome [2] 3822 0
Left ventricular function assessed by MRI
Timepoint [2] 3822 0
at baseline and 20 weeks after randomisation
Secondary outcome [1] 6445 0
Body composition assessed by Dual energy X-ray absorptiometry (DEXA) scan
Timepoint [1] 6445 0
at baseline and 20 weeks after randomisation
Secondary outcome [2] 6446 0
Arterial flow assessed by ultrasound
Timepoint [2] 6446 0
at baseline and 20 weeks after randomisation
Secondary outcome [3] 6447 0
Glycemic control (HbA1c) assessed by blood test
Timepoint [3] 6447 0
at baseline and 20 weeks after randomisation

Eligibility
Key inclusion criteria
Type 1 Diabetes as defined by the American Association of Diabetes
Minimum age
14 Years
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if: body mass index < 16 or > 40 kg/m2 or percentage of fat > 40%; hypertension defined as resting systolic blood pressure >140mmHg and/or diastolic pressure >90mmHg; evidence or history of musculoskeletal or cardiovascular disease; use of cardiovascular or hypertensive medication; evidence of diabetic complications; any contraindication for MRI scans and pregnancy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

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 outside Australia
Country [1] 782 0
New Zealand
State/province [1] 782 0

Funding & Sponsors
Funding source category [1] 3062 0
Charities/Societies/Foundations
Name [1] 3062 0
The National Heart Foundation of New Zealand
Address [1] 3062 0
National Office
9 Kalmia St, Ellerslie
PO Box 17160, Greenlane
Auckland
Country [1] 3062 0
New Zealand
Funding source category [2] 3063 0
Charities/Societies/Foundations
Name [2] 3063 0
Maurice & Phyllis Paykel Trust
Address [2] 3063 0
PO Box 37760
Parnell, Auckland
Country [2] 3063 0
New Zealand
Funding source category [3] 3064 0
Other Collaborative groups
Name [3] 3064 0
Australasian Paediatric Endocrine Group
Address [3] 3064 0
PO Box 180
Morrisset NSW
Country [3] 3064 0
Australia
Primary sponsor type
Individual
Name
Dr Paul Hofman
Address
Liggins Institute 85 Park Rd, Grafton Auckland NZ
University of Auckland 1023
Private Bag 92019
Country
New Zealand
Secondary sponsor category [1] 2759 0
Individual
Name [1] 2759 0
Miss Silmara Gusso
Address [1] 2759 0
Liggins Institute 85 Park Rd, Grafton Auckland NZ
University of Auckland 1023
Private Bag 92019
Country [1] 2759 0
New Zealand
Secondary sponsor category [2] 2760 0
Individual
Name [2] 2760 0
Dr Wayne Cutfield
Address [2] 2760 0
Liggins Institute 85 Park Rd, Grafton Auckland NZ
University of Auckland 1023
Private Bag 92019
Country [2] 2760 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296669 0
Northern X Ethics Committee
Ethics committee address [1] 296669 0
Ministry of Health
3rd floor Unisys Building
650 Great South Rd, Penrose 1051
private Bag 92522
Ethics committee country [1] 296669 0
New Zealand
Date submitted for ethics approval [1] 296669 0
10/05/2011
Approval date [1] 296669 0
16/09/2011
Ethics approval number [1] 296669 0
NTX/11/05/042

Summary
Brief summary
Aerobic capacity is reduced in adults with type 1 diabetes (T1D). Structural and functional changes of the heart and vessels may play an important role on the decreased aerobic capacity in T1D. Exercise training in T1D adults has demonstrated increased aerobic capacity and decreased insulin use. However the exact impact of training on cardiac and vascular function and structure has yet to be established. In T1D adolescents the changes in cardiovascular morphology and function remain less defined. Signs of cardiovascular abnormalities have been observed at rest. However other studies have found no functional or structural cardiovascular changes. T1D adolescents already have reduced aerobic capacity. However, few studies have examined the causes for this reduction and the impact of exercise training and none have investigated the impact of training on heart and vessels structure or function. Considering that T1D adolescents have been exposed to diabetes for a short period of time and will face years of exposure to the diabetes health related risks, they form an important group of interest. Therefore this study aims to investigate the cardiovascular function and structure of T1D adolescents using magnetic resonance imaging and ultrasound and to examine the impact of 20 weeks of exercise training on the cardiac and vascular function and structure.
Trial website
Trial related presentations / publications
Two articles were published with the study results.
Gusso, S., Pinto, T., Baldi, J. C., Derraik, J. G., Cutfield, W. S., Hornung, T., & Hofman, P. L. (2017). Exercise training improves but does not normalize left ventricular systolic and diastolic function in adolescents with type 1 diabetes. Diabetes Care, 40(9), 1264-1272. doi:10.2337/dc16-2347

Gusso, S., Pinto, T., Baldi, J., Robinson, E., Cutfield, W., & Hofman, P. (2012). Diastolic function is reduced in adolescents with type 1 diabetes in response to exercise. Diabetes Care, 35(10), 2089-2094. doi:10.2337/dc11-2331
Public notes

Contacts
Principal investigator
Name 28358 0
Prof Paul Hofman
Address 28358 0
85 Park Rd, Grafton. Auckland, NZ. Postal code 1023
Country 28358 0
New Zealand
Phone 28358 0
+64 9 923 6453
Fax 28358 0
Email 28358 0
p.hofman@auckland.ac.nz
Contact person for public queries
Name 11515 0
Dr Silmara Gusso
Address 11515 0
Liggins Institute 85 Park Rd, Grafton Auckland NZ
University of Auckland Private Bag 92019. Postal code 1023
Country 11515 0
New Zealand
Phone 11515 0
+ 64 9 923 3795
Fax 11515 0
+64 9 373 8763
Email 11515 0
s.gusso@auckland.ac.nz
Contact person for scientific queries
Name 2443 0
Prof Dr Paul Hofman
Address 2443 0
Liggins Institute 85 Park Rd, Grafton Auckland NZ
University of Auckland Private Bag 92019
Postal Code 1023
Country 2443 0
New Zealand
Phone 2443 0
+ 64 9 373 7599 ext 86453
Fax 2443 0
+64 9 373 8763
Email 2443 0
p.hofman@auckland.ac.nz

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