Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/02/2006
Date assigned
24/02/2006
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas M Wolever

ORCID ID

Contact details

Department of Nutritional Sciences
150 College Street
Room 316
Toronto
M5S 3E2
Canada
+1 416 978 5556
thomas.wolever@utoronto.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00223574

Protocol/serial number

MCT-44205

Study information

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)

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).

Ethics approval

University of Toronto Research Ethics Board, St Michael's Hospital gave approval on the 19th December 2001

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2001

Overall trial end date

31/01/2004

Reason abandoned

Eligibility

Participant 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%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

168

Participant 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

Recruitment start date

01/04/2001

Recruitment end date

31/01/2004

Locations

Countries of recruitment

Canada

Trial participating centre

Department of Nutritional Sciences
Toronto
M5S 3E2
Canada

Sponsor information

Organisation

University of Toronto (Canada)

Sponsor details

27 King's College Circle
Toronto
M5S 1A1
Canada

Sponsor type

University/education

Website

http://www.utoronto.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44205)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Wolever TM, Gibbs AL, Mehling C, Chiasson JL, Connelly PW, Josse RG, Leiter LA, Maheux P, Rabasa-Lhoret R, Rodger NW, Ryan EA, The Canadian Trial of Carbohydrates in Diabetes (CCD), a 1-y controlled trial of low-glycemic-index dietary carbohydrate in type 2 diabetes: no effect on glycated hemoglobin but reduction in C-reactive protein., Am. J. Clin. Nutr., 2008, 87, 1, 114-125.

  2. Disposition index results

    Wolever TM, Mehling C, Chiasson JL, Josse RG, Leiter LA, Maheux P, Rabasa-Lhoret R, Rodger NW, Ryan EA, Low glycaemic index diet and disposition index in type 2 diabetes (the Canadian trial of carbohydrates in diabetes): a randomised controlled trial., Diabetologia, 2008, 51, 9, 1607-1615, doi: 10.1007/s00125-008-1093-x.

  3. Results

    Wolever TM, Gibbs AL, Chiasson JL, Connelly PW, Josse RG, Leiter LA, Maheux P, Rabasa-Lhoret R, Rodger NW, Ryan EA, Altering source or amount of dietary carbohydrate has acute and chronic effects on postprandial glucose and triglycerides in type 2 diabetes: Canadian trial of Carbohydrates in Diabetes (CCD)., Nutr Metab Cardiovasc Dis, 2013, 23, 3, 227-234, doi: 10.1016/j.numecd.2011.12.011.

Additional files

Editorial Notes