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Long-term effect of altering the source and amount of dietary carbohydrate in type 2 diabetes
ISRCTN ISRCTN81151522
DOI 10.1186/ISRCTN81151522
ClinicalTrials.gov identifier NCT00223574
EudraCT number
Public title Long-term effect of altering the source and amount of dietary carbohydrate in type 2 diabetes
Scientific title Comparison of the long-term effect of reducing the glycaemic index versus reducing the amount of dietary carbohydrate in type 2 diabetes: a randomised controlled trial
Acronym CCD (Canadian trial of dietary Carbohydrates in Diabetes)
Serial number at source MCT-44205
Study hypothesis To compare the effects, in subjects with diabetes treated by diet alone, of reducing glycaemic load by replacing high glycaemic index (GI) starchy foods with low GI starchy foods (i.e. reducing diet GI) versus low carbohydrate foods rich in monounsaturated fat (i.e. reducing the amount of dietary carbohydrate).
Lay summary Not provided at time of registration
Ethics approval University of Toronto Research Ethics Board, St Michael's Hospital gave approval on the 19th December 2001
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Diabetes mellitus
Participants - inclusion criteria 1. Male or non-pregnant females
2. Aged 40 - 70 years old
3. Body mass index less than 40 kg/m^2
4. HbA1c less than or equal to 8.5%
Participants - exclusion criteria 1. Absence of diabetes
2. Age less than 40 years or greater than 70 years
3. Pregnancy or lactation
4. Body mass index greater than or equal to 40 kg/m^2
5. Use of any hypoglycaemic or anti-hyperglycaemic drug
6. HbA1c greater than 8.5%
7. Major cardiovascular event (stroke, myocardial infraction) or surgery within six months
8. Serum triglycerides greater than 10 mmol/l
9. Presence of other major debilitating disorder such as liver disease, renal failure, cancer
10. Presence of gastrointestinal disorder or use of a drug which is likely to alter gastrointestinal motility or nutrient absorption
11. Substance abuse
12. Simultaneous participation in another clinical trial
Anticipated start date 01/04/2001
Anticipated end date 31/01/2004
Status of trial Completed
Patient information material
Target number of participants 168
Interventions Group 1 - high carbohydrate, high glycaemic index starchy foods (control); duration 12 months
Group 2 - high carbohydrate, low glycaemic index starchy foods; duration 12 months
Group 3 - low carbohydrate foods, high in monounsaturated fat; duration 12 months

Trial details received: 12 Sept 2005
Primary outcome measure(s) Glycated haemoglobin (A1c) measured at -2 and 0 weeks and at 3, 6, 9 and 12 months after randomisation (measure at 12 months is done twice; at 50 and 52 weeks).
Secondary outcome measure(s) 1. Fasting plasma: total, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triglycerides, Apolipoprotein A (Apo A), Apolipoprotein B (Apo B), C-reactive protein (CRP), free fatty acids (FFA), glucose, insulin, acetate, propionate, butyrate all measured at baseline and at 1, 3, 6, 9 and 12 months after randomisation
2. Oral glucose tolerance: area under curve (AUC) for glucose and insulin, two-hour glucose, insulinogenic index measured at baseline and at 3, 6 and 12 months after randomisation. Eight-hour metabolic profile for glucose, insulin, triglycerides and FFA measured at baseline and 12 months after randomisation.
3. Body weight, waist circumference, blood pressure measured at 2 - 4 week intervals throughout the trial
4. Quality of life and activity index measured at baseline and 12 months after randomisation
5. Intakes of carbohydrate, fiber, starch, sugars, total fat, saturated fat, polyunsaturated fatty acids (PUFA) and monounsaturated fatty acids (MUFA), protein, glycaemic index and glycaemic load measured using a three-day food record two times at baseline and 1, 3, 6, 9 and 12 months after randomisation
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44205)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18175744
2. 2008 disposition index results in http://www.ncbi.nlm.nih.gov/pubmed/18648764
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22397878
Contact name Dr  Thomas M  Wolever
  Address Department of Nutritional Sciences
150 College Street, Room 316
  City/town Toronto
  Zip/Postcode M5S 3E2
  Country Canada
  Tel +1 416 978 5556
  Fax +1 416 978 5882
  Email thomas.wolever@utoronto.ca
Sponsor University of Toronto (Canada)
  Address 27 King's College Circle
  City/town Toronto
  Zip/Postcode M5S 1A1
  Country Canada
  Sponsor website: http://www.utoronto.ca/
Date applied 24/02/2006
Last edited 05/04/2012
Date ISRCTN assigned 24/02/2006
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