Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001162909
Ethics application status
Not yet submitted
Date submitted
7/11/2011
Date registered
7/11/2011
Date last updated
7/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Capillary Recruitment in Patients with Type 2 Diabetes Mellitus
Scientific title
Does an intensive exercise intervention in patients with type 2 diabetes mellitus improve skeletal muscle blood flow and glycaemic control?
Secondary ID [1] 273344 0
Nil
Universal Trial Number (UTN)
U1111-1125-6956
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 279110 0
Condition category
Condition code
Metabolic and Endocrine 279304 279304 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise intervention to improve blood flow to skeletal muscle thereby decreasing insulin resistance and improving gycaemic control. Those randomised to the intervention will participate in a 12 week intensive exercise program 3 times per week (1 hour) consisting of a combination of aerobic and resistance exercises tailored to the patient. They will then be given a home exercise program tailored to them by an accredited exercise physiologist. The intensive exercise program will be repeated at the end of one year. Exercise sessions will be in small groups approximately 6-8 participants.
Intervention code [1] 283684 0
Treatment: Other
Intervention code [2] 283685 0
Lifestyle
Comparator / control treatment
Usual care. Usual care consists of any regular medical care or clinic visits perscribed for their diabetes. No other interventions will be initiated or treatment withheld
Control group
Active

Outcomes
Primary outcome [1] 279913 0
Increased blood volume in skeletal muscle. This will be assessed using ultrasound and and ultrasound contrast agent (Definity) which is approved for use in Australia
Timepoint [1] 279913 0
2 years
Secondary outcome [1] 294765 0
Improvement in systolic and diasolic left ventricular function.
This will be assessed using echocardiography.
Timepoint [1] 294765 0
2 years
Secondary outcome [2] 294766 0
Improvement in functional capacity. This will be assessed by exercise stress echocardiography with measurement of peak oxygen consumption (VO2)
Timepoint [2] 294766 0
2 years

Eligibility
Key inclusion criteria
Type 2 diabetes
able to exercise
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of any cardiovascular disease
history of stroke
end stage renal disease
pregnancy
terminal disease

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284166 0
University
Name [1] 284166 0
University of Queensland
Country [1] 284166 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Princess Alexandra Hospital
Ipswich Rd
Brisbane, Qld 4102
Country
Australia
Secondary sponsor category [1] 269123 0
None
Name [1] 269123 0
None
Address [1] 269123 0
Country [1] 269123 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286128 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 286128 0
Centres for Health Research
Princess Alexandra Hospital
Ispwich Rd
Brisbane, Qld 4102
Ethics committee country [1] 286128 0
Australia
Date submitted for ethics approval [1] 286128 0
11/11/2011
Approval date [1] 286128 0
Ethics approval number [1] 286128 0

Summary
Brief summary
We will recruit 200 patients with T2DM between the ages of 25 and 65 with no history of coronary artery disease (CAD) or cardiovascular complications. We anticipate numbers of men and women to be roughly equal. All testing will take place at Princess Alexandra Hospital in the cardiovascular clinical measurements department and intensive exercise sessions will also be held at the Princess Alexandra hospital in the cardiovascular imaging research centre gym. The primary outcome variable of this study will be:
1. Increased capillary recruitment and glycaemic control
Secondary outcomes measures will be:
1. Improvement in left ventricular systolic and diastolic function
2. Improvement in functional capacity.
Trial website
None
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 33359 0
Address 33359 0
Country 33359 0
Phone 33359 0
Fax 33359 0
Email 33359 0
Contact person for public queries
Name 16606 0
Brian Haluska PhD
Address 16606 0
University of Queensland School of Medicine
Princess Alexandra Hospital
Ipswich Rd, Brisbane, Qld 4102
Country 16606 0
Australia
Phone 16606 0
+61 7 3176 5829
Fax 16606 0
+61 7 3176 5399
Email 16606 0
[email protected]
Contact person for scientific queries
Name 7534 0
Brian Haluska PhD
Address 7534 0
University of Queensland School of Medicine
Princess Alexandra Hospital
Ipswich Rd, Brisbane, Qld 4102
Country 7534 0
Australia
Phone 7534 0
+61 7 3176 5829
Fax 7534 0
+61 7 3176 5399
Email 7534 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.