Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473811
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2007-05-14
Brief Title:
Diabetic Educational Eating Plan
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Applicability of a Low Glycemic Index Diet in Diabetes
Status:
COMPLETED
Status Verified Date:
2012-08
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:
DEEP
Brief Summary:
By improving glycemic control many of the devastating complications of diabetes are to a large extent preventable The use of a low GI glycemic index diet to improve glycemic control is relatively new and untested However a low GI diet may be a cost-effective approach to preventing diabetes-related complications The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention to reduce dietary GI in patients with type 2 diabetes and to compare it with a nutritionist-delivered standard American Diabetes Association ADA diet intervention Our outcomes are recruitment and retention rates as well as physiological measures HbA1c blood lipids blood pressure and body mass index dietary GI scores and acceptability of the intervention
Primary hypotheses
1 Recruitment and retention rates for the low GI intervention will be satisfactory
Secondary hypotheses
1 Participants in the low GI intervention group will show more favorable changes in physiological measures than participants in the ADA diet group
2 Participants in the low GI group will be successful in lowering the GI of their diet
3 Participants will find the intervention acceptable
Primary hypotheses
1 Recruitment and retention rates for the low GI intervention will be satisfactory
Secondary hypotheses
1 Participants in the low GI intervention group will show more favorable changes in physiological measures than participants in the ADA diet group
2 Participants in the low GI group will be successful in lowering the GI of their diet
3 Participants will find the intervention acceptable
Detailed Description:
The glycemic index GI is a ranking of carbohydrate containing foods according to the rate at which they raise blood glucose levels after eating A recent meta-analysis of randomized clinical trials RCT suggests that choosing low GI foods has a small but clinically useful effect on medium-term glycemic control in patients with type 2 diabetes However in most of the reviewed RCTs patients were fed experimental diets and therefore there is still controversy over the applicability of GI in the clinical setting for management of diabetes In addition there is no evidence that long-term consumption of a low GI diet will contribute to improved glycemic control in people with diabetes
Our ultimate goal for a future larger RCT is to evaluate the long-term effects of using low GI diet in type 2 diabetics The primary outcome variable of the future large trial will be glycosylated hemoglobin levels HbA1c a measure reflecting average glycemic level during the preceding 2-3 months The proposed feasibility study will recruit 40 patients with type 2 diabetes and will randomly assign them to one of two groups a low GI nutrition education group low GI group and a standard ADA dietary education group as the control group ADA group 20 patients in each group
For both groups the intervention phase will last 6 months and consist of an initial group session an individual session and then four group counseling sessions The follow-up phase will be six months and consist of two group booster sessions one at 8-months and another at 10-months The low GI nutritional education will be primarily targeted at a low GI diet The focus is not on decreasing total carbohydrate intake but rather encouraging patients to substitute low GI foods for high GI foods The dietary intervention will be based on a patient-centered counseling model which has been demonstrated to facilitate health behavior change Data collection points coincide with two phases of the intervention Assessments including demographics anthropometric measurements diet and physical activity recalls and clinical data will be conducted at baseline and at 6 and 12 months after randomization with blood samples collected at each interval We will track response to recruitment adherence and retention Quantitative and qualitative methods will be used to assess acceptability of the intervention
The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention to reduce dietary GI in patients with type 2 diabetes Our outcomes are recruitment and retention rates as well as physiological measures HbA1c blood pressure and body mass index dietary GI scores and acceptability of the intervention
By improving glycemic control many of the devastating complications of diabetes are to a large extent preventable The use of a low GI diet to improve glycemic control is relatively new and untested However a low GI diet may be a cost-effective approach to preventing diabetes-related complications Testing the feasibility of such a program and its potential impact would be an important step towards an RO1 application to the NIH
Our ultimate goal for a future larger RCT is to evaluate the long-term effects of using low GI diet in type 2 diabetics The primary outcome variable of the future large trial will be glycosylated hemoglobin levels HbA1c a measure reflecting average glycemic level during the preceding 2-3 months The proposed feasibility study will recruit 40 patients with type 2 diabetes and will randomly assign them to one of two groups a low GI nutrition education group low GI group and a standard ADA dietary education group as the control group ADA group 20 patients in each group
For both groups the intervention phase will last 6 months and consist of an initial group session an individual session and then four group counseling sessions The follow-up phase will be six months and consist of two group booster sessions one at 8-months and another at 10-months The low GI nutritional education will be primarily targeted at a low GI diet The focus is not on decreasing total carbohydrate intake but rather encouraging patients to substitute low GI foods for high GI foods The dietary intervention will be based on a patient-centered counseling model which has been demonstrated to facilitate health behavior change Data collection points coincide with two phases of the intervention Assessments including demographics anthropometric measurements diet and physical activity recalls and clinical data will be conducted at baseline and at 6 and 12 months after randomization with blood samples collected at each interval We will track response to recruitment adherence and retention Quantitative and qualitative methods will be used to assess acceptability of the intervention
The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention to reduce dietary GI in patients with type 2 diabetes Our outcomes are recruitment and retention rates as well as physiological measures HbA1c blood pressure and body mass index dietary GI scores and acceptability of the intervention
By improving glycemic control many of the devastating complications of diabetes are to a large extent preventable The use of a low GI diet to improve glycemic control is relatively new and untested However a low GI diet may be a cost-effective approach to preventing diabetes-related complications Testing the feasibility of such a program and its potential impact would be an important step towards an RO1 application to the NIH
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