Trial Review

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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
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.