Long-term effect of altering the source and amount of dietary carbohydrate in type 2 diabetes
| ISRCTN | ISRCTN81151522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81151522 |
| ClinicalTrials.gov number | NCT00223574 |
| Secondary identifying numbers | MCT-44205 |
- Submission date
- 24/02/2006
- Registration date
- 24/02/2006
- Last edited
- 05/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thomas M Wolever
Scientific
Scientific
Department of Nutritional Sciences
150 College Street, Room 316
Toronto
M5S 3E2
Canada
| Phone | +1 416 978 5556 |
|---|---|
| thomas.wolever@utoronto.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study acronym | CCD (Canadian trial of dietary Carbohydrates in Diabetes) |
| Study objectives | 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). |
| Ethics approval(s) | University of Toronto Research Ethics Board, St Michael's Hospital gave approval on the 19th December 2001 |
| Health condition(s) or problem(s) studied | Diabetes mellitus |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/04/2001 |
| Completion date | 31/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 168 |
| Key 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% |
| Key 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 |
| Date of first enrolment | 01/04/2001 |
| Date of final enrolment | 31/01/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
Department of Nutritional Sciences
Toronto
M5S 3E2
Canada
M5S 3E2
Canada
Sponsor information
University of Toronto (Canada)
University/education
University/education
27 King's College Circle
Toronto
M5S 1A1
Canada
| Website | http://www.utoronto.ca/ |
|---|---|
"ROR" |
https://ror.org/03dbr7087 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44205)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2008 | Yes | No | |
| Results article | disposition index results | 01/09/2008 | Yes | No | |
| Results article | results | 01/03/2013 | Yes | No |
