Effects of a Mediterranean Style Diet on Vascular Health in Type 2 Diabetes

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes; Coronary Heart Disease	Behavioral: Dietary Therapy	Not Applicable

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The primary outcomes include: HBAIc and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 6 months after dietary intervention

Secondary Outcome Measures :

1. Key secondary outcomes include: TNF-a, IL-6, High sensitivity CRP, plasma carotenoids and serum fatty acids.

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

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).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3181

Sponsors and Collaborators

Bayside Health

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00163683 History of Changes
Other Study ID Numbers:	A33420
First Posted:	September 14, 2005
Last Update Posted:	December 5, 2013
Last Verified:	September 2005

Keywords provided by Bayside Health:

Dietary Intervention

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Glucose Metabolism Disorders	Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases