title: Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial.
abstract: Type 2 diabetes (T2DM) produces macrovascular and microvascular damage, significantly increasing the risk of cardiovascular disease (CVD), renal failure and blindness. As rates of T2DM rise, the need for effective dietary and other lifestyle changes to improve diabetes management become more urgent. Low-glycaemic index (GI) diets may improve glycaemic control in diabetes in the short term; however, there is a lack of evidence on the long-term adherence to low-GI diets, as well as on the association with surrogate markers of CVD beyond traditional risk factors. Recently, advances have been made in measures of subclinical arterial disease through the use of MRI, which, along with standard measures from carotid ultrasound (CUS) scanning, have been associated with CVD events. We therefore designed a randomised, controlled, clinical trial to assess whether low-GI dietary advice can significantly improve surrogate markers of CVD and long-term glycaemic control in T2DM.
  
  
  
  169 otherwise healthy individuals with T2DM were recruited to receive intensive counselling on a low-GI or high-cereal fibre diet for 3 years. To assess macrovascular disease, MRI and CUS are used, and to assess microvascular disease, retinal photography and 24-hour urinary collections are taken at baseline and years 1 and 3. Risk factors for CVD are assessed every 3 months.
  
  
  
  The study protocol and consent form have been approved by the research ethics board of St. Michael's Hospital. If the study shows a benefit, these data will support the use of low-GI and/or high-fibre foods in the management of T2DM and its complications.
  
  
  
  NCT01063374; Pre-results.
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Laura
authors.initials: L
authors.lastname: Chiavaroli
authors.affiliation: Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada Faculty of Health Sciences, School of Medicine, Queen's University, Kingston, Ontario, Canada.
authors.forename: Arash
authors.initials: A
authors.lastname: Mirrahimi
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: Ireland
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Sandra
authors.initials: S
authors.lastname: Mitchell
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Sandhya
authors.initials: S
authors.lastname: Sahye-Pudaruth
authors.affiliation: Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Judy
authors.initials: J
authors.lastname: Coveney
authors.affiliation: Department of Medical Imaging, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Omodele
authors.initials: O
authors.lastname: Olowoyeye
authors.affiliation: Department of Medical Imaging, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Tishan
authors.initials: T
authors.lastname: Maraj
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Darshna
authors.initials: D
authors.lastname: Patel
authors.affiliation: Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Russell J
authors.initials: RJ
authors.lastname: de Souza
authors.affiliation: Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada National Cancer Institute "Fondazione G. Pascale", Naples, Italy.
authors.forename: Livia S A
authors.initials: LS
authors.lastname: Augustin
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Balachandran
authors.initials: B
authors.lastname: Bashyam
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Sonia
authors.initials: S
authors.lastname: Blanco Mejia
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Stephanie K
authors.initials: SK
authors.lastname: Nishi
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Division of Endocrinology and Metabolism, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Leiter
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Division of Endocrinology and Metabolism, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Josse
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Gail
authors.initials: G
authors.lastname: McKeown-Eyssen
authors.affiliation: Department of Medical Imaging, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Moody
authors.affiliation: Department of Ophthalmology, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Berger
authors.affiliation: Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
authors.forename: Cyril W C
authors.initials: CW
authors.lastname: Kendall
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: John L
authors.initials: JL
authors.lastname: Sievenpiper
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: David J A
authors.initials: DJ
authors.lastname: Jenkins
mesh_terms: D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging / Q000453:epidemiology*; D002339:Carotid Arteries / Q000000981:diagnostic imaging*; D059168:Carotid Intima-Media Thickness; D003131:Combined Modality Therapy; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy* / Q000188:drug therapy / Q000378:metabolism; D004043:Dietary Fiber / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000378:metabolism; D038321:Glycemic Index; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008279:Magnetic Resonance Imaging; D009864:Ontario; D012307:Risk Factors
chemical_list: D004043:Dietary Fiber; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human
keywords: cardiovascular disease; carotid plaque; diabetes; dietary fiber; glycemic index; randomized clinical trial