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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Coronary Heart Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0

Study type
Description of intervention(s) / exposure
Behaviour - Dietary Therapy

Behaviour: Dietary Therapy

Intervention code [1] 0 0
Comparator / control treatment
Control group

Primary outcome [1] 0 0
The primary outcomes include: HBAIc and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 6 months after dietary intervention
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Key secondary outcomes include: TNF-a, IL-6, High sensitivity CRP, plasma carotenoids and serum fatty acids.
Timepoint [1] 0 0

Key inclusion criteria
-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
30 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- age <30 years or > 75 years;

- 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 µg per minute or ALT more than twice
the upper limit of normal respectively).

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

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Bayside Health

Ethics approval
Ethics application status

Brief summary
In this study we will compare the effects of a Mediterranean diet, high in fruit and
vegetables with the more conventional diet recommended for diabetes therapy (a high
carbohydrate, low fat diet) on glycaemic and lipid control and on markers of inflammation, in
people with newly diagnosed Type 2 diabetes. The hypothesis is that, over a six-month
intervention period, a HVM diet will be more effective than a conventional HCLF diet in
improving glycaemic and lipid control, and in reducing markers of vascular inflammation in
people with Type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Rachel M Stoney, PhD
Address 0 0
Alfred Hospital, Melbourne, AUSTRALIA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications