Low glycaemic index diet for type 2 diabetics
| ISRCTN | ISRCTN01033037 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01033037 |
| ClinicalTrials.gov number | NCT01063374 |
| Secondary identifying numbers | 09-193; MCT-98825 |
- Submission date
- 13/01/2010
- Registration date
- 18/01/2010
- Last edited
- 28/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes is a condition where the pancreas doesn't produce enough insulin or the body's cells don't react to insulin, causing the blood sugar level to become too high. The aim of this study is to determine how the type of foods in a diet can affect blood sugar control and heart and blood vessel health in people with type 2 diabetes. The glycaemic index is a scale that ranks carbohydrate foods by how much they raise blood sugar levels compared to a standard food. In this study a low glycaemic index diet is compared to a standard healthy high fibre diet.
Who can participate?
Patients aged over 21 with type 2 diabetes
What does the study involve?
Participants are randomly allocated to be given dietary advice on either a low glycaemic index diet or a high fibre diet. They are required to keep a 7-day food record every 3 months throughout the 3-year study. Blood tests and body measurements are carried out every 3 months. Participants undergo MRI and ultrasound scans to look at the walls of the carotid arteries, the largest blood vessels in the neck. Retinal photographs are taken to look at the arteries in the eye. The MRI, ultrasound, and eye tests are done at the beginning of the study, after 1 year, and at the end (3 years).
What are the possible benefits and risks of participating?
This study assesses whether this dietary help can improve risk factors for heart disease. This may not benefit participants, but may improve how patients are treated in the future. There are small risks with having blood drawn and if a contrast dye is used for the MRI, which are explained in the consent form.
Where is the study run from?
1. St Michael's Hospital (Canada)
2. University of Toronto (Canada)
When is the study starting and how long is it expected to run for?
February 2010 to August 2016
Who is funding the study?
Canadian Institutes of Health Research (Canada)
Who is the main contact?
Dr David Jenkins
Contact information
Scientific
61 Queen St. East, 6th Floor
Toronto
M5C 2T2
Canada
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Low glycaemic index diets to improve glycaemic control and cardiovascular disease in type 2 diabetics: a randomised controlled trial |
| Study objectives | A low glycaemic index diet will improve glycaemic control and plaque build-up in type 2 diabetics, compared to a high fibre diet. |
| Ethics approval(s) | St Michael's Hospital Research Ethics Board, 16/12/2009, ref: REB09-093 |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | Participants will be randomly assigned to receive dietary counselling for either a low glycaemic index diet, or a high cereal fibre diet for a three year period. Subjects will be followed for 3 years after starting the study. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 15/09/2016: Plaque volume, assessed by MRI at 1 and 3 years Previous primary outcome measures: 1. Carotid intima media thickness 2. HbA1c 3. Plasma glucose and lipids Magnetic resonance imaging (MRI) of intima media will take place at 0, 1 year, and 3 years. Blood tests and clinic visits will take place every 3 months during the 3 years. |
| Secondary outcome measures | Current secondary outcome measures as of 15/09/2016: 1. Intima media thickness, assessed by 3D carotid ultrasound at 1 and 3 years 2. Plaque morphology measured at 1 and 3 years 3. HbA1c measured every 3 months for 3 years 4. Serum lipids measured every 3 months for 3 years 5. Blood pressure measured every 3 months for 3 years 6. Serum fasting glucose measured every 3 months for 3 years 7. Creatinine, urea, and C-peptides in 24 hour urine collection measured at 1 and 3 years 8. Anthropometric measures (weight, waist and hip circumference), measured every 3 months for 3 years 9. Retinal photography measured at 1 and 3 years Previous secondary outcome measures: 1. Anthropometric measures 2. Blood and urine tests Blood tests and clinic visits will take place every 3 months during the 3 years. |
| Overall study start date | 01/02/2010 |
| Completion date | 01/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 160 |
| Key inclusion criteria | Current inclusion criteria as of 15/09/2016: 1. Type 2 diabetes diagnosed for greater than 6 months 2. Men and women aged over 21 years 3. Stable dose of hypoglycaemic medication 4. HbA1c between 6.5 and 8.0 at screening, and pre-study visit 5. Stable weight 6. Family physician and valid health card 7. Stable dose of lipid medication, if prescribed 8. Stable dose of blood pressure medication, if prescribed 9. Ability to keep written food records, use digital food scale Previous inclusion criteria: 1. Type 2 diabetes dignosed for greater than 6 months 2. Men and post-menopausal women, aged over 21 years 3. Stable dose of hypoglycaemic medication 4. HbA1c between 6.5 and 8% 5. Stable weight 6. Family physician and valid health card 7. Stable dose of lipid medication, if prescribed 8. Stable dose of blood pressure medication, if prescribed 9. Ability to keep written food records, use digital food scale |
| Key exclusion criteria | 1. Insulin, steroids, or warfarin 2. Gastrointestinal disease 3. Major cardiovascular event in past 6 months 4. Major surgery in past 6 months 5. Liver disease, hepatitis B or C 6. Renal failure 7. Major debilitating disorder 8. Serum triglycerides greater than 6 mmol/L 9. History of cancer (except non-melanoma skin cancer) 10. Pre-menopausal women 11. Food allergies to study foods 12. Blood pressure above 145/90 mmHg 13. Acute or chronic infections 14. Chronic inflammatory diseases 15. Inability to undergo magnetic resonance imaging (MRI) 16. Any other condition which make one unsuitable for the study |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 01/05/2013 |
Locations
Countries of recruitment
- Canada
Study participating centre
M5C 2T2
Canada
Sponsor information
Hospital/treatment centre
30 Bond St
Toronto
M5B 1W8
Canada
| Website | http://www.stmichaelshospital.com |
|---|
University/education
Department of Nutritional Sciences
Faculty of Medicine
150 College St, Room 340
Toronto
M5S 3E2
Canada
| Website | www.utoronto.ca |
|---|
Not defined
| Website | http://www.stmichaelshospital.com/ |
|---|---|
"ROR" |
https://ror.org/04skqfp25 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/07/2016 | Yes | No | |
| Interim results article | baseline data | 22/03/2017 | Yes | No |
Editorial Notes
28/05/2019: Internal review.
10/04/2019: Publication reference added.
27/09/2016: Plain English summary added.
15/09/2016: the overall trial end date was changed from 01/09/2015 to 01/08/2016.
