An interventional study of Dietary Therapy in Type 2 Diabetes and Coronary Heart Disease, sponsored by Bayside Health. Completed at 1 site in Australia. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-05.
Sponsored by Bayside Health · Not applicable and Interventional
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 24 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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-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.
Exclusion Criteria:
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.
This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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