|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| Long-term effect of altering the source and amount of dietary carbohydrate in type 2 diabetes |
| ISRCTN | ISRCTN81151522 |
| ClinicalTrials.gov identifier | NCT00223574 |
| 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 |
| 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 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|