Effects of a Mediterranean Style Diet on Vascular Health in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00163683|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Coronary Heart Disease||Behavioral: Dietary Therapy||Not Applicable|
Chronic inflammation affecting both small and large blood vessels is an important factor increasing the risk of heart disease in people with Type 2 diabetes. Good markers present in the blood are now available to detect this inflammatory state. Recent evidence suggests that a Mediterranean-type diet, high in plant foods and with monounsaturated fat from olive oil has beneficial effects on blood vessels as well as on blood glucose and blood lipid control.
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). Twenty-four people with Type 2 diabetes will be randomised to one of these diets and followed for six months. At the end of this time, the effect of the diets on markers for inflammation will be compared.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
- The primary outcomes include: HBAIc and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 6 months after dietary intervention
- Key secondary outcomes include: TNF-a, IL-6, High sensitivity CRP, plasma carotenoids and serum fatty acids.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163683
|Melbourne, Victoria, Australia, 3181|
|Principal Investigator:||Rachel M Stoney, PhD||Alfred Hospital, Melbourne, AUSTRALIA|
|Study Director:||Karen Z Walker, PhD||Monash University|
|Study Director:||Duncan Topliss, FRACP||Alfred Hospital, Melbourne, AUSTRALIA|