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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00163683




Registration number
NCT00163683
Ethics application status
Date submitted
11/09/2005
Date registered
14/09/2005
Date last updated
5/12/2013

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
A33420
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
Diabetes

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

Behaviour: Dietary Therapy
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00163683
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163683