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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163683
First received: September 11, 2005
Last updated: December 3, 2013
Last verified: September 2005
  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
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

Resource links provided by NLM:


Further study details as provided by Bayside Health:

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.

Enrollment: 24
Study Start Date: January 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Melbourne Australia
Study Director: Duncan Topliss, FRACP Alfred Hospital, Melbourne, AUSTRALIA
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00163683     History of Changes
Other Study ID Numbers: A33420
Study First Received: September 11, 2005
Last Updated: December 3, 2013
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 September 14, 2014