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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Coronary Heart Disease

Keywords

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Dietary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Dietary Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel M Stoney, PhD

Role: PRINCIPAL_INVESTIGATOR

Alfred Hospital, Melbourne, AUSTRALIA

Karen Z Walker, PhD

Role: STUDY_DIRECTOR

Monash University

Duncan Topliss, FRACP

Role: STUDY_DIRECTOR

Alfred Hospital, Melbourne, AUSTRALIA

Locations

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Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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A33420

Identifier Type: -

Identifier Source: org_study_id