Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000368538
Ethics application status
Approved
Date submitted
15/08/2006
Date registered
23/08/2006
Date last updated
14/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of sprint training in type 1 diabetes
Scientific title
Sprint training effects upon muscle metabolism and ion regulation in type 1 diabetes mellitus during and after high intensity exercise
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 1337 0
Condition category
Condition code
Metabolic and Endocrine 1425 1425 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
7 weeks of high-intensity cycle sprint training: 3 sessions per week; 4 x 30 second sprints with 4 minutes rest in Week 1; incremented by 2 sprints per session per week in Weeks 2, 3, and 4, then rest period reduced to 3 minutes with 10 sprints per session in Weeks 5, 6, and 7 - session duration between 30 - 60 minutes, according to week of training.
Intervention code [1] 1309 0
Treatment: Other
Comparator / control treatment
Comparison of responses in subjects with and without type 1 diabetes.
Control group
Active

Outcomes
Primary outcome [1] 1948 0
Muscle (vastus lateralis) sodium potassium adenosine triphosphatase (Na+K+ATPase) content
Timepoint [1] 1948 0
Measured at rest at 0 and 8 weeks of training
Primary outcome [2] 1949 0
Muscle [lactate]
Timepoint [2] 1949 0
Measured before and immediately after a high intensity exercise at 0 and 8 weeks of training only
Secondary outcome [1] 3410 0
Glycosylated haemoglobin (HbA1c)
Timepoint [1] 3410 0
Measured at rest at 0 and 8 weeks
Secondary outcome [2] 3411 0
Plasma glucose
Timepoint [2] 3411 0
Measured at 0 and 8 weeks during a high-intensity exercise test at rest, immediately after exercise, and at 1, 2, 5, 10, 20, 30, 45, and 60 min of recovery.
Secondary outcome [3] 3412 0
Plasma potassium (K+) - measured as per glucose
Timepoint [3] 3412 0
Secondary outcome [4] 3413 0
Plasma hydrogen ion (H+) - measured as per glucose
Timepoint [4] 3413 0
Secondary outcome [5] 3414 0
Plasma lactate concentration - measured as per glucose
Timepoint [5] 3414 0
Secondary outcome [6] 3415 0
Muscle pyruvate concentration- measured as per primary outcome of muscle lactate
Timepoint [6] 3415 0
Secondary outcome [7] 3416 0
Catecholamines
Timepoint [7] 3416 0
Measured during a high intensity exercise test at 0 and 8 weeks at rest, immediately after exercise, and at 1, 2, 5, 10, 20 and 60 min recovery.
Secondary outcome [8] 3417 0
Plasma glucose, plasma potassium and plasma hydrogen ion concentration
Timepoint [8] 3417 0
Measured before and after 4 x 30 s cycle sprints and at 4, 5, 12, and 20 min recovery, both at 0 weeks and in the final training session of week 7.

Eligibility
Key inclusion criteria
Group with type 1 diabetes, inclusion: diabetes for at least 1.5 yrs; taking no medications other than insulin; no evidence of diabetic complications such as proliferative retinopathy (>10 microaneurysms in previous year) or autonomic or peripheral neuropathies; HbA1c < 10%.
Non-diabetic control group, inclusion: no history or family history of any metabolic disorder.
Both groups, inclusion: not currently undertaking high-intensity exercise training; non-smokers; no medications.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Group with type 1 diabetes, exclusions: taking mediaction other than insulin; HbA1c >10%; presence of diabetic complications; diabetes for < 1.5 years.
Non-diabetic control group, exclusions: taking medication; family or personal history of metabolic disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/1996
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1557 0
University
Name [1] 1557 0
School of Exercise & Sports Science, The University of Sydney
Country [1] 1557 0
Australia
Primary sponsor type
Individual
Name
Dr Alison Harmer
Address
Country
Secondary sponsor category [1] 1370 0
University
Name [1] 1370 0
School of Exercise & Sports Science, The University of Sydney
Address [1] 1370 0
Country [1] 1370 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2988 0
School of Exercise & Sports Science, The University of Sydney
Ethics committee address [1] 2988 0
Ethics committee country [1] 2988 0
Australia
Date submitted for ethics approval [1] 2988 0
Approval date [1] 2988 0
06/12/1995
Ethics approval number [1] 2988 0
95/12/34
Ethics committee name [2] 2989 0
Diabetes Clinic at Lidcombe-Bankstown Hospital
Ethics committee address [2] 2989 0
Ethics committee country [2] 2989 0
Australia
Date submitted for ethics approval [2] 2989 0
Approval date [2] 2989 0
Ethics approval number [2] 2989 0
96/47

Summary
Brief summary
Younger subjects with type 1 diabetes are being encouraged to undertake exercise, with no limitation on type/intensity of exercise (providing that there are no complications of diabetes present, e.g. cardiovascular disease), however, there is very little scientific information on the response of those with type 1 diabetes to intense exercise, and almost no studies on the response of these patients to high intensity exercise training. This study aimed to compare the metabolic (e.g. blood and muscle lactate, blood glucose) and ionic responses (e.g. muscle sodium potassium adenosine triphosphatase, blood potassium, blood acidosis) during high intensity exercise, as reflected in samples of blood, muscle, and expired gas analysis, in younger people with and without type 1 diabetes; and secondly to evaluate the responses of both groups to high intensity exercise training. We hypothesised that acute exercise responses would be similar in the subjects with and without type 1 diabetes; and that high intensity exercise training would improve metabolic and ionic responses during high intensity exercise in subjects with type 1 diabetes; and would not result in deterioration of overall metabolic control (reflected by glycosylated haemoglobin).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27970 0
Address 27970 0
Country 27970 0
Phone 27970 0
Fax 27970 0
Email 27970 0
Contact person for public queries
Name 10498 0
Dr Alison Harmer
Address 10498 0
School of Physiotherapy,
Faculty of Health Sciences,
The University of Sydney,
PO Box 170, Lidcombe, NSW 1825
Country 10498 0
Australia
Phone 10498 0
+61 2 93519706
Fax 10498 0
+61 2 93519278
Email 10498 0
[email protected]
Contact person for scientific queries
Name 1426 0
Dr Alison Harmer
Address 1426 0
School of Physiotherapy,
Faculty of Health Sciences,
The University of Sydney,
PO Box 170, Lidcombe, NSW 1825
Country 1426 0
Australia
Phone 1426 0
+61 2 93519706
Fax 1426 0
+61 2 93519278
Email 1426 0
[email protected]

No information has been provided regarding IPD availability


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.