Effects of a Mediterranean Style Diet on Vascular Health in Type 2 Diabetes
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Type 2 Diabetes Coronary Heart Disease |
Behavioral: Dietary Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| 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 |
- 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.
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2003 |
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.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Rachel M Stoney, PhD | +613 9276 3063 | r.stoney@alfred.org.au |
| Contact: Karen Walker, PhD | +613 9594 4472 | karen.walker@med.monash.edu.au |
| Australia, Victoria | |
| Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3181 | |
| Contact: Rachel M Stoney, PhD +61 3 9276 3063 r.stoney@alfred.org.au | |
| Contact: Karen Z Walker, PhD +61 3 95944472 karen.walker@med.monash.edu.au | |
| Principal Investigator: Rachel M Stoney, PhD | |
| Principal Investigator: | Rachel M Stoney, PhD | Alfred Hospital, Melbourne, AUSTRALIA |
| Study Director: | Karen Z Walker, PhD | Monash University, Melbourne, AUSTRALIA |
| Study Director: | Duncan Topliss, FRACP | Alfred Hospital, Melbourne, AUSTRALIA |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00163683 History of Changes |
| Other Study ID Numbers: | A33420 |
| Study First Received: | September 11, 2005 |
| Last Updated: | November 15, 2005 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by Bayside Health:
|
Dietary Intervention |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013