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 (NCT)	NCT00223574
Protocol serial number	MCT-44205
Sponsor	University of Toronto (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

Department of Nutritional Sciences
150 College Street, Room 316
Toronto
M5S 3E2
Canada

Phone	+1 416 978 5556
Email	thomas.wolever@utoronto.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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).
Key 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
Completion date	31/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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