Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Participants will be randomly assigned to receive dietary counselling for either a low glycaemic index diet, or a high cereal fibre diet for a three year period. Subjects will be followed for 3 years
Sponsors
St Michael's Hospital (Canada)
University of Toronto (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/09/2016: 1. Type 2 diabetes diagnosed for greater than 6 months 2. Men and women aged over 21 years 3. Stable dose of hypoglycaemic medication 4. HbA1c between 6.5 and 8.0 at screening, and pre-study visit 5. Stable weight 6. Family physician and valid health card 7. Stable dose of lipid medication, if prescribed 8. Stable dose of blood pressure medication, if prescribed 9. Ability to keep written food records, use digital food scale Previous inclusion criteria: 1. Type 2 diabetes dignosed for greater than 6 months 2. Men and post-menopausal women, aged over 21 years 3. Stable dose of hypoglycaemic medication 4. HbA1c between 6.5 and 8% 5. Stable weight 6. Family physician and valid health card 7. Stable dose of lipid medication, if prescribed 8. Stable dose of blood pressure medication, if prescribed 9. Ability to keep written food records, use digital food scale
Exclusion criteria
Exclusion criteria: 1. Insulin, steroids, or warfarin 2. Gastrointestinal disease 3. Major cardiovascular event in past 6 months 4. Major surgery in past 6 months 5. Liver disease, hepatitis B or C 6. Renal failure 7. Major debilitating disorder 8. Serum triglycerides greater than 6 mmol/L 9. History of cancer (except non-melanoma skin cancer) 10. Pre-menopausal women 11. Food allergies to study foods 12. Blood pressure above 145/90 mmHg 13. Acute or chronic infections 14. Chronic inflammatory diseases 15. Inability to undergo magnetic resonance imaging (MRI) 16. Any other condition which make one unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/09/2016: Plaque volume, assessed by MRI at 1 and 3 years Previous primary outcome measures: 1. Carotid intima media thickness 2. HbA1c 3. Plasma glucose and lipids Magnetic resonance imaging (MRI) of intima media will take place at 0, 1 year, and 3 years. Blood tests and clinic visits will take place every 3 months during the 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/09/2016: 1. Intima media thickness, assessed by 3D carotid ultrasound at 1 and 3 years 2. Plaque morphology measured at 1 and 3 years 3. HbA1c measured every 3 months for 3 years 4. Serum lipids measured every 3 months for 3 years 5. Blood pressure measured every 3 months for 3 years 6. Serum fasting glucose measured every 3 months for 3 years 7. Creatinine, urea, and C-peptides in 24 hour urine collection measured at 1 and 3 years 8. Anthropometric measures (weight, waist and hip circumference), measured every 3 months for 3 years 9. Retinal photography measured at 1 and 3 years Previous secondary outcome measures: 1. Anthropometric measures 2. Blood and urine tests Blood tests and clinic visits will take place every 3 months during the 3 years. | — |
Countries
Canada
Outcome results
None listed