Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000286347
Ethics application status
Approved
Date submitted
11/04/2008
Date registered
4/06/2008
Date last updated
4/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of exercise options in newly-diagnosed patients with type 2 diabetes mellitus
Scientific title
A randomised trial of exercise training versus standard guideline-based care on vascular function in subjects with newly-diagnosed type 2 diabetes mellitus
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 3036 0
Condition category
Condition code
Metabolic and Endocrine 3187 3187 0 0
Diabetes
Physical Medicine / Rehabilitation 3188 3188 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparing intensive exercise regime (physiotherapy led sessions – 3x 1hr per week) with standard guideline exercise (self led 30 minutes of moderate exertion on most days per week).
Total duration of study is 22 weeks (once 32 subjects have been recruited)
There will be 2 weeks between crossing over.
Intervention code [1] 2779 0
Prevention
Intervention code [2] 2780 0
Treatment: Other
Intervention code [3] 2781 0
Lifestyle
Comparator / control treatment
1st arm - Comparison of intensive exercise regime versus active control. Active control includes exercise advice given as standard care out with the trial.
2nd arm - Comparison of self directed exercise program following New Zealand guidelines on exercise versus active control. Active control includes exercise advice given as standard care out with the trial.
Control group
Active

Outcomes
Primary outcome [1] 4075 0
Change in flow-mediated dilation in the brachial artery in the forearm before and after the administration of sub-lingual Glyceryl trinitrate. We will be using a portable ultrasound device (General Electrics ? Logiq e) to make the brachial artery measurements.
Timepoint [1] 4075 0
At baseline, and after each 8 week exercise intervention (which may include active control)
Secondary outcome [1] 6861 0
Central aortic blood pressure
Timepoint [1] 6861 0
at baseline, and after each 8 week exercise intervention (which may include active control)
Secondary outcome [2] 6862 0
Change in mean brachial blood pressure
Timepoint [2] 6862 0
At baseline, and after each 8 week exercise intervention (which may include active control)
Secondary outcome [3] 6863 0
Change in fasting lipid levels (cholesterol, HDL-c, & triglyceride). This will be assessed using blood samples.
Timepoint [3] 6863 0
At baseline, and after each 8 week exercise intervention (which may include active control)
Secondary outcome [4] 6864 0
Change in urine albumin:creatinine ratio
Timepoint [4] 6864 0
At baseline, and after each 8 week exercise intervention (which may include active control)
Secondary outcome [5] 6865 0
Change in insulin resistance as calculated by homeostasis model assessment of insulin resistance (HOMA-IR).
Timepoint [5] 6865 0
At baseline, and after each 8 week exercise intervention (which may include active control)
Secondary outcome [6] 6866 0
Change in Quality of life as measured by the Short Form 36 (SF-36) Questionnaire.
Timepoint [6] 6866 0
At baseline, and after each 8 week exercise intervention (which may include active control)

Eligibility
Key inclusion criteria
Patients to be included in this protocol must:
1. Be aged >30 years and =60 years
2. Have type 2 diabetes mellitus (maximum of 2 years since diagnosis) in accordance with American Diabetes Association criteria treated with diet or metformin oral hypoglycemic medication with an HbA1c 6.5-10% at baseline.
3. Provide written informed consent to participate in the study
Minimum age
30 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient with any of the following conditions prior to randomisation will not be enrolled into the study:
1. Diabetic nephropathy (urine albumin creatinine ratio (ACR) >200mg/mmol)
2. Known non-diabetic renal disease as indicated by haematuria, active urinary sediment or casts
3. Serum creatinine >150 µmol/L in men and ?130 µmmol/L in women
4. Morbid obesity with body mass >160kg
5. Abnormal baseline Electrocardiogram (ECG), or inducible ischaemic changes on baseline exercise tolerance test
6. Pregnant, nursing a child, or planning a pregnancy at the time of this study
7. History of type 1 diabetes defined as age of onset <20 years and/or history of continuous treatment with insulin since diagnosis
8. History of cigarette smoking, drug or alcohol abuse
9. Co-morbid conditions that are likely t o affect ability to participate in an exercise program:
a. Severe chronic obstructive pulmonary disease (COPD) as evidenced by hospitalization for decompensation within 6 months of randomization, chronic treatment with oral steroids, or a resting oxygen saturation (SAO2) <90 mm Hg
b. Congestive heart failure (CHF) corresponding with New York Heart Association (NYHA) Class II, III and IV or an N-terminal pro-brain natriuretic peptide (NT-proBNP) level >350
c. Severe ischaemic heart disease (IHD) with acute coronary event, and/or coronary artery bypass graft (CABG), and/or percutaneous coronary intervention (PCI) in the previous 60 days.
d. Severe peripheral vascular disease
e. Severe arthritic disease of the feet, knees, hips, or lower spine
f. Severe liver disease with icterus and plasma bilirubin =60 µmmol/L, plasma transaminase = 3-fold upper limit of normal, albumin <30 g/L or coagulopathy
g. Hematological disorders including hemoglobin <110 g/L or platelet count < 80,000/mm3
10. Gastrointestinal bleeding in the previous 60 days,
11. Malignancy other than basal cell carcinoma.
12. Any other disease or condition which in the opinion of the investigator could make them unsuitable for entry.

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)
Allocation will involve contacting the holder of the allocation schedule who is at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
2 separate parallel cross-over groups
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 912 0
New Zealand
State/province [1] 912 0

Funding & Sponsors
Funding source category [1] 3289 0
Charities/Societies/Foundations
Name [1] 3289 0
Centre for Clinical Research & effective practice (CCRep)
Country [1] 3289 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Centre for Clinical Research & effective practice (CCRep)
Address
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 2943 0
None
Name [1] 2943 0
Address [1] 2943 0
Country [1] 2943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5274 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5274 0
Ethics committee country [1] 5274 0
New Zealand
Date submitted for ethics approval [1] 5274 0
Approval date [1] 5274 0
12/02/2008
Ethics approval number [1] 5274 0
NTX/07/12/136

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

Contacts
Principal investigator
Name 28519 0
Address 28519 0
Country 28519 0
Phone 28519 0
Fax 28519 0
Email 28519 0
Contact person for public queries
Name 11676 0
Dr Kenneth Muir
Address 11676 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 11676 0
New Zealand
Phone 11676 0
+64 9 276 0044 extn 2946
Fax 11676 0
Email 11676 0
[email protected]
Contact person for scientific queries
Name 2604 0
Dr Ajith Dissnayake
Address 2604 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 2604 0
New Zealand
Phone 2604 0
+64 21 977 839
Fax 2604 0
Email 2604 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.