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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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A low glycemic index diet may improve glycemic control and reduce plaque buildup in arteries of those with type 2 diabetes. Subjects will be randomly assigned to receive dietary advice on either a low glycemic index diet, or a high cereal fibre diet, for three years.
All subjects will be randomized to one 3-year treatment in a two-treatment parallel design.
Treatments:
Study Details: Fasting blood samples are obtained at screening, week -2, and months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 each study period. HbA1c will be assessed on all visits. A carotid ultrasound (CUS) (screening, months 0, 12 and 36) and magnetic resonance imaging (MRI) (months 0, 12 and 36) technologies will be used to assess arterial wall thickening and changes in the nature of carotid plaques. Twenty-four hour urine for urinary C-peptide analyses will be obtained immediately prior to the beginning of the study and at the end of each 3 year treatment phase. At the end of the 3 year treatment period, subjects who wish to undertake the alternate treatment will be given appropriate instruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low glycemic index, diabetic diet | Active Comparator | low glycemic index, diabetic diet |
|
| high cereal fibre, diabetic diet | Active Comparator | high cereal fibre, diabetic diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low glycemic diet instruction | Dietary Supplement |
| ||
| high cereal fibre diet instruction |
| Measure | Description | Time Frame |
|---|---|---|
| plaque volume | 1, 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| intima media thickness | 0, 1, and 3 years | |
| plaque morphology | 0, 1, 3 years | |
| HbA1c |
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Inclusion Criteria:
Men and women with type 2 diabetes who
Exclusion Criteria: Individuals who
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| Name | Affiliation | Role |
|---|---|---|
| David Mazer | St. Michael's Hospital Research Ethics Board | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada | ||
| Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28336747 | Derived | Chiavaroli L, Mirrahimi A, Ireland C, Mitchell S, Sahye-Pudaruth S, Coveney J, Olowoyeye O, Patel D, de Souza RJ, Augustin LS, Bashyam B, Pichika SC, Blanco Mejia S, Nishi SK, Leiter LA, Josse RG, McKeown-Eyssen GE, Moody AR, Kendall CW, Sievenpiper JL, Jenkins DJ. Cross-sectional associations between dietary intake and carotid intima media thickness in type 2 diabetes: baseline data from a randomised trial. BMJ Open. 2017 Mar 22;7(3):e015026. doi: 10.1136/bmjopen-2016-015026. | |
| 27388364 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Dietary Supplement |
|
| every 3 months for 3 years |
| serum lipids | every 3 months for 3 years |
| blood pressure | every 3 months for 3 years |
| serum fasting glucose | creatinine, urea, and C-peptides in 24 hour urine collection |
| anthropometric measures (weight, waist and hip circumference) | every 3 months for 3 years |
| retinal photography | ophthalmological assessment using fundoscopy | 1, 3 years |
| Toronto |
| Ontario |
| M5C 2T2 |
| Canada |
| Derived |
| Chiavaroli L, Mirrahimi A, Ireland C, Mitchell S, Sahye-Pudaruth S, Coveney J, Olowoyeye O, Maraj T, Patel D, de Souza RJ, Augustin LS, Bashyam B, Blanco Mejia S, Nishi SK, Leiter LA, Josse RG, McKeown-Eyssen G, Moody AR, Berger AR, Kendall CW, Sievenpiper JL, Jenkins DJ. Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial. BMJ Open. 2016 Jul 7;6(7):e012220. doi: 10.1136/bmjopen-2016-012220. |
| D004700 | Endocrine System Diseases |