Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124553
Status:
UNKNOWN
Last Update Posted:
2007-03-28
First Post:
2005-07-27
Brief Title:
LOADD Lifestyle Over and Above Drugs in Diabetes Study
Sponsor:
Edgar National Centre for Diabetes Research
Organization:
Edgar National Centre for Diabetes Research
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
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 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
Detailed Description:
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
The control group will receive usual dietary advice and diabetes treatment from their usual GP and practice nurse as detailed in the Management of Type 2 Diabetes and The Assessment and Management of Cardiovascular Risk guidelines published in December 2003 12
In addition to usual care the intervention group will receive intensive instruction about a recommended dietary pattern based on the recently published recommendations of the Nutrition Study Group of the European Association for the Study of Diabetes 3 and where appropriate use material for example serving size information from the above mentioned guidelines
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
1 New Zealand Guidelines Group The assessment and management of cardiovascular risk Wellington NZ December 2003 httpwwwnzggorgnz
2 New Zealand Guidelines Group Management of Type 2 diabetes Wellington NZ December 2003 httpwwwnzggorgnz
3 Mann JI De Leeuw I Hermansen K Karamanos B Karlstrom B Katsilambros N Riccardi G Rivellese AA Rizkalla S Slama G Toeller M Uusitupa M Vessby B Nutr Metab Cardiovasc Dis 14373-394 2004
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
The control group will receive usual dietary advice and diabetes treatment from their usual GP and practice nurse as detailed in the Management of Type 2 Diabetes and The Assessment and Management of Cardiovascular Risk guidelines published in December 2003 12
In addition to usual care the intervention group will receive intensive instruction about a recommended dietary pattern based on the recently published recommendations of the Nutrition Study Group of the European Association for the Study of Diabetes 3 and where appropriate use material for example serving size information from the above mentioned guidelines
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
1 New Zealand Guidelines Group The assessment and management of cardiovascular risk Wellington NZ December 2003 httpwwwnzggorgnz
2 New Zealand Guidelines Group Management of Type 2 diabetes Wellington NZ December 2003 httpwwwnzggorgnz
3 Mann JI De Leeuw I Hermansen K Karamanos B Karlstrom B Katsilambros N Riccardi G Rivellese AA Rizkalla S Slama G Toeller M Uusitupa M Vessby B Nutr Metab Cardiovasc Dis 14373-394 2004
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