Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000399695
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a Mediterranean style diet on vascular health in Type 2 diabetes.
Scientific title
The effect of a Mediterranean style diet versus a conventional High carbohydrate, low fat diet on glycaemic and lipid control and on vascular inflammatory markers in people with newly diagnosed type 2 diabetes.
Secondary ID [1] 163 0
HVM Dietary Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 505 0
Condition category
Condition code
Metabolic and Endocrine 583 583 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of a randomised six-month dietary intervention with individuals assigned to either the intervention group (HVM diet) or the control group (High carbohydrate, low fat: HCLF diet). Each group receives individualised dietary education and is provided with written dietary education materials. Subjects attend for review at 3 and 6 months, and are also contacted by telephone after the first month. Outcome measures are assessed at study entry and after six months of dietary therapy. Measures of glycaemic control and standard lipids are analysed and analysis undertaken for assessment of biomarkers of inflammation and endothelial cell function as well as markers of dietary adherence.
Intervention code [1] 398 0
Lifestyle
Comparator / control treatment
Control group (High carbohydrate, low fat: HCLF diet).
Control group
Active

Outcomes
Primary outcome [1] 676 0
HBAIc at study entry and 6 months after dietary intervention
Timepoint [1] 676 0
At study entry and 6 months after dietary intervention
Primary outcome [2] 677 0
Lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 6 months after dietary intervention
Timepoint [2] 677 0
At study entry and 6 months after dietary intervention
Secondary outcome [1] 1384 0
TNF-a, IL-6, High sensitivity CRP, plasma carotenoids and serum fatty acids.
Timepoint [1] 1384 0
These biochemical parameters are measured at study entry (baseline) and at six months post completion of the dietary intervention period.

Eligibility
Key inclusion criteria
For our study we are recruiting 24 English speaking people with newly diagnosed Type 2 diabetes (within 3-12 months of diagnosis) who are attending the Alfred Hospital, Diabetes Education Outpatient Clinic.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
body mass index (BMI) < 25 kg/m2 or >37 kg/m2; on corticosteroid or insulin therapy; presence of established renal and/or liver disease (serum creatinine more than 0.12 mmol/L/albumin excretion rate greater than 300 ÿµg per minute or ALT more than twice the upper limit of normal respectively).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Odd numbers are assigned to the intervention group (HVM diet) while even numbers are assigned to the control group (HCLF diet). Randomisation is noted blinded as the clinician provides dietary education to enrolled participants and participants upon allocation are aware of the dietary intervention that they have been assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As subjects were recruited they were systematically assigned a random number moving downward on the first of Table8, Random Sampling Numbers Cambridge Elementary Statistical Tablesâ¿¿, Cambridge University Press.
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
Recruiting
Date of first participant enrolment
Anticipated
1/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 636 0
Hospital
Name [1] 636 0
Small Project Grant 2002, Alfred Hospital
Country [1] 636 0
Australia
Funding source category [2] 637 0
Hospital
Name [2] 637 0
Allied Health Research Grant 2004, Alfred Hospital
Country [2] 637 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital, Melbourne
Address
Country
Australia
Secondary sponsor category [1] 529 0
None
Name [1] 529 0
Not applicable
Address [1] 529 0
Country [1] 529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1768 0
Alfred Hospital
Ethics committee address [1] 1768 0
Ethics committee country [1] 1768 0
Australia
Date submitted for ethics approval [1] 1768 0
Approval date [1] 1768 0
Ethics approval number [1] 1768 0

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

Contacts
Principal investigator
Name 35662 0
Address 35662 0
Country 35662 0
Phone 35662 0
Fax 35662 0
Email 35662 0
Contact person for public queries
Name 9587 0
Dr Rachel Stoney
Address 9587 0
Alfred Hospital
Commercial Rd
Melbourne SA 3181
Country 9587 0
Australia
Phone 9587 0
+61 3 92763063
Fax 9587 0
+61 3 92763059
Email 9587 0
[email protected]
Contact person for scientific queries
Name 515 0
Dr Rachel Stoney
Address 515 0
Alfred Hospital
Commercial Rd
Melbourne SA 3181
Country 515 0
Australia
Phone 515 0
+61 3 92763063
Fax 515 0
+61 3 92763059
Email 515 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.