Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000306314
Ethics application status
Approved
Date submitted
24/06/2008
Date registered
26/06/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effect of resistance exercise on blood glucose levels in Type 1 diabetes
Scientific title
Acute effect of resistance exercise on blood glucose levels in Type 1 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 3304 0
Condition category
Condition code
Metabolic and Endocrine 3468 3468 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Blood glucose is measured continuously during two 3-day periods. During one of these 3-day periods, a 1 hour resistance exercise session is performed consisting of the following exercises: Bench Press, Leg Extensions, Upright Row, Lateral Pull-downs, Dumbbell Flys, squats and abdominal crunches. During the other 3-day period no exercise is performed. Each participant acts as their own control and completes both 3-day periods with a minimum of 3 days washout in between.
Intervention code [1] 3045 0
Other interventions
Comparator / control treatment
No exercise.
Control group
Active

Outcomes
Primary outcome [1] 4371 0
Blood glucose (measured continuously)
Timepoint [1] 4371 0
Baseline (pre-exercise/control), Day 1 (Exercise/Control session and following evening), Day 1 overnight, Day 2, Day 2 overnight, and Day 3.
Secondary outcome [1] 7376 0
Safety - post resistance exercise hypoglycemia. Hypoglycemic will be assesses by examining blood glucose levels following resistance exercise compared to rest. This will be measured from the continuous glucose monitor downloaded data.
Timepoint [1] 7376 0
Total time spent with blood glucose level below 3.5mmol/l in the 48 hours following resistance exercise compared to rest.

Eligibility
Key inclusion criteria
Type 1 diabetes
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of hypoglycemic unawareness, untreated proliferative retinopathy, proteinuria, cardiovascular disease, any absolute exercise contraindications.

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)
A Treatment session (1-hour resistance exercise) and control (no exercise) is conducted by each participant during the two 3-day periods in random order. Order determined for each partciipant by random selection of sealed envelope containing order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Total of 16 envelopes - half sealed envelopes contained exercie/rest and half contained rest/exercise.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3513 0
Commercial sector/Industry
Name [1] 3513 0
Novo Nordisk Regional Diabetes Support Scheme
Country [1] 3513 0
Australia
Funding source category [2] 3514 0
Commercial sector/Industry
Name [2] 3514 0
Medtronic Minimed
Country [2] 3514 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk Regional Diabetes Support Scheme
Address
PO Box 863, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 3154 0
Other
Name [1] 3154 0
International Diabetes Institute
Address [1] 3154 0
250 Kooyong Road, Caulfield, VIC 3162
Country [1] 3154 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5549 0
International Diabetes Institute Ethics Committee
Ethics committee address [1] 5549 0
Ethics committee country [1] 5549 0
Australia
Date submitted for ethics approval [1] 5549 0
Approval date [1] 5549 0
22/01/2005
Ethics approval number [1] 5549 0
7/2004

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

Contacts
Principal investigator
Name 28697 0
Address 28697 0
Country 28697 0
Phone 28697 0
Fax 28697 0
Email 28697 0
Contact person for public queries
Name 11854 0
Carol Robinson
Address 11854 0
International Diabetes Institute
250 Kooyong Road, Caulfield, VIC 3162
Country 11854 0
Australia
Phone 11854 0
(03) 9258 5075
Fax 11854 0
(03) 9258 5090
Email 11854 0
[email protected]
Contact person for scientific queries
Name 2782 0
Carol Robinson
Address 2782 0
International Diabetes Institute
250 Kooyong Road, Caulfield, VIC 3162
Country 2782 0
Australia
Phone 2782 0
(03) 9258 5075
Fax 2782 0
(03) 9258 5090
Email 2782 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.