Viewing Study NCT00163683



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00163683
Status: COMPLETED
Last Update Posted: 2013-12-05
First Post: 2005-09-11

Brief Title: Effects of a Mediterranean Style Diet on Vascular Health in Type 2 Diabetes
Sponsor: Bayside Health
Organization: Bayside Health

Study Overview

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
Status: COMPLETED
Status Verified Date: 2005-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None