Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Edgar National Centre for Diabetes Research University of Otago |
---|---|
Information provided by: | Edgar National Centre for Diabetes Research |
ClinicalTrials.gov Identifier: | NCT00124553 |
In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes (T2DM). More recently, this aspect of treatment has received less attention as drug therapy aimed not only to lower glucose, but also to treat raised blood pressure and blood fats (including cholesterol) has been more widespread. While there is evidence to suggest that blood pressure and blood fat levels have improved, overall diabetes control has not and people with diabetes appear to be becoming progressively more overweight, following trends in the general population. The proposed study involves a randomised controlled trial in which people with T2DM continuing with their regular drug treatment and surveillance, will be randomly allocated to additionally receive intensive advice regarding diet or remain on their usual treatment in this regard. The results will be judged principally in terms of body weight, waist circumference, blood pressure, blood glucose control and blood fats.
Condition | Intervention |
---|---|
Type 2 Diabetes Mellitus |
Behavioral: Intensive dietary advice |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease |
Estimated Enrollment: | 220 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | June 2008 |
This is a 6-month pilot intervention study which seeks to determine whether adherence to an intensive evidence based dietary programme, in addition to the prescription of both cardioprotective and hypoglycaemic medications recommended for patients with diabetes, will provide health benefits in terms of reducing the risk of developing or progression of complications of diabetes (particularly cardiovascular disease).
The specific aim of the project is to compare the effects of an intensive lifestyle intervention (based on the recently published evidence based recommendations of the Nutrition Study Group of the European Association for the Study of Diabetes [3]) or usual dietary advice, in diabetic patients at high risk of cardiovascular disease, treated with cardioprotective and hypoglycaemic drugs.
Study participants will be randomised into two groups:
Outcome will be determined by examining surrogate markers of clinical endpoints. These surrogate markers will include clinical measures (weight, body mass index, blood pressure) and appropriate tests (haemoglobin A1c, fasting insulin, blood lipids, lipoproteins, inflammatory markers, and urine albumin creatinine ratio). A quality of life questionnaire will also be administered at the beginning and end of the project.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Chris S Booker, BSc(Hons) | 64-3-474-7775 | chris.booker@stonebow.otago.ac.nz |
Contact: Kirsten Coppell, FAFPHM | 64-3-474-7774 | kirsten.coppell@stonebow.otago.ac.nz |
New Zealand, Otago | |
Edgar National Centre for Diabetes Research | Recruiting |
Dunedin, Otago, New Zealand, 9001 | |
Contact: Chris S Booker, BSc(Hons) 64-3-474-7775 chris.booker@stonebow.otago.ac.nz | |
Contact: Kirsten Coppell, FAFPHM 64-3-474-7774 kirsten.coppell@stonebow.otago.ac.nz | |
Principal Investigator: Jim I Mann, FRACP |
Principal Investigator: | Jim I Mann, FRACP | Edgar National Centre for Diabetes Research |
Principal Investigator: | Kirsten Coppell, FAFPHM | Edgar National Centre for Diabetes Research |
Study ID Numbers: | ENCDR_1 |
Study First Received: | July 27, 2005 |
Last Updated: | March 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00124553 History of Changes |
Health Authority: | New Zealand: Health and Disability Ethics Committees |
Type 2 diabetes cardiovascular risk glycaemic control dietary modification |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |