Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000060448
Ethics application status
Approved
Date submitted
13/01/2007
Date registered
18/01/2007
Date last updated
18/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of lifestyle modification and active risk factor intervention on myocardial and vascular structure and reactivity in diabetes mellitus
Scientific title
The effect of exercise training and dietary intervention in apparently healthy subjects with type II diabetes mellitus in preventing cardiovascular disease
Universal Trial Number (UTN)
Trial acronym
LIFESTYLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subclinical cardiovascular disease in type II diabetes 1554 0
Condition category
Condition code
Metabolic and Endocrine 1653 1653 0 0
Diabetes
Cardiovascular 1654 1654 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention/s: The intervention group will undergo a 3-year program targeting lifestyle factors important in the development of cardiovascular complications of diabetes, and comprising 3 components;
1) Exercise training (both aerobic and strength training) will start with 1 month of twice-weekly supervised training, in combination with a home training program. After the supervised period, the program will be adjusted and patients will continue with this at home. Ongoing telephone contact will be maintained and the program altered according to progress.
2) Dietary advice will start with weekly dietician visits for 3 months. These will include weighing, 6 minute walk, review of dietary intake and education. Ongoing dietary advice will continue by provision of telephone contact and “refresher” courses every 6 months.
3) Ongoing personalized support and counselling by the study nurse, to ensure attendance for testing and optimize compliance with guideline-based medical therapy by the patient’s general practitioner, including aggressive management of insulin resistance and glucose levels.
Intervention code [1] 1553 0
Prevention
Comparator / control treatment
The control group will also be studied over 3 years, but their management will be restricted to treatment of diabetes according to guidelines.
Control group
Active

Outcomes
Primary outcome [1] 2285 0
Aggressive lifestyle intervention (supervised dietary modification and exercise training) in type 2 diabetes improves 1) attainment of glycemic and lipid control
Timepoint [1] 2285 0
After 3 years
Primary outcome [2] 2286 0
ggressive lifestyle intervention (supervised dietary modification and exercise training) in type 2 diabetes improves 2) exercise capacity
Timepoint [2] 2286 0
After 3 years
Primary outcome [3] 2287 0
ggressive lifestyle intervention (supervised dietary modification and exercise training) in type 2 diabetes improves 3)myocardial markers (tissue velocity and strain)
Timepoint [3] 2287 0
After 3 years
Primary outcome [4] 2288 0
ggressive lifestyle intervention (supervised dietary modification and exercise training) in type 2 diabetes improves 4) vascular function (arterial compliance), 5) endothelial function (brachial reactivity) and atherosclerotic burden (intima-medial thickness)
Timepoint [4] 2288 0
After 3 years
Primary outcome [5] 2289 0
ggressive lifestyle intervention (supervised dietary modification and exercise training) in type 2 diabetes improves 1) attainment of glycemic and lipid control, 2) exercise capacity, 3)myocardial markers (tissue velocity and strain), 4) vascular function (arterial compliance), 5) endothelial function (brachial reactivity) and atherosclerotic burden (intima-medial thickness)
Timepoint [5] 2289 0
After 3 years
Secondary outcome [1] 3990 0
1) Supervised exercise training and lifestyle intervention in type 2 diabetes improve myocardial markers (tissue velocity and strain) and vascular markers (arterial compliance and brachial reactivity).
Timepoint [1] 3990 0
After 1 month
Secondary outcome [2] 3991 0
2) Supervised lifestyle intervention in type 2 diabetes improves myocardial markers (tissue velocity and strain) and vascular markers (arterial compliance and brachial reactivity).
Timepoint [2] 3991 0
After 3 months
Secondary outcome [3] 3992 0
3) Aggressive lifestyle intervention (supervised dietary modification and exercise training) in type 2 diabetes improves survival.
Timepoint [3] 3992 0
After 3 years

Eligibility
Key inclusion criteria
Adults with type 2 diabetes including patients attending the Princess Alexandra Hospital Diabetes Clinic and patients recruited from the local community via advertisements.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable/unwilling to comply with frequent follow-up, currently enrolled in another investigational study, life expectancy is severely limited due to pre-existing malignancy or other disease (<6 months), pregnancy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1800 0
Government body
Name [1] 1800 0
National Health and Medical Research Council
Country [1] 1800 0
Australia
Primary sponsor type
Individual
Name
Professor T Marwick
Address
Country
Secondary sponsor category [1] 1619 0
None
Name [1] 1619 0
none
Address [1] 1619 0
Country [1] 1619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3361 0
Princess Alexandra Hospital
Ethics committee address [1] 3361 0
Ethics committee country [1] 3361 0
Australia
Date submitted for ethics approval [1] 3361 0
Approval date [1] 3361 0
12/01/2003
Ethics approval number [1] 3361 0
2003/006

Summary
Brief summary
Patients with type 2 diabetes are at risk of developing cardiovascular disease. Lifestyle changes and an exercise program may reduce damage to the structure and function of blood vessels and improve heart function. In this trial, subjects with type 2 diabetes will be randomly assigned to one of two groups – “Usual care” (ie standard treatment of diabetes according to guidelines) or “Active intervention” (additional measures such as frequent follow-up, additional dietary advice and an exercise program, in addition to usual care). The efficacy of these interventions on cardiovascular structure and function, exercise capacity, attainment of target biochemistry and outcome will be assessed after 1 month, 1 year and 3 years
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27487 0
Address 27487 0
Country 27487 0
Phone 27487 0
Fax 27487 0
Email 27487 0
Contact person for public queries
Name 10742 0
Melody Downey RN
Address 10742 0
Department of Medicine
University of Queensland
Princess Alexandra Hospital
Brisbane QLD 4102
Country 10742 0
Australia
Phone 10742 0
+61 7 32406429
Fax 10742 0
+61 7 32405399
Email 10742 0
[email protected]
Contact person for scientific queries
Name 1670 0
Professor Thomas Marwick
Address 1670 0
Department of Medicine
University of Queensland
Princess Alexandra Hospital
Brisbane QLD 4102
Country 1670 0
Australia
Phone 1670 0
+61 7 32405340
Fax 1670 0
+61 7 32405399
Email 1670 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.