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

Sponsor:

Information provided by (Responsible Party):

Bayside Health

Study Description

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


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 2 diabetes

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Older Adult)
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

Information from the National Library of Medicine

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

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


Responsible Party:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00163683 History of Changes
Other Study ID Numbers:	A33420
First Posted:	September 14, 2005 Key Record Dates
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

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