Low glycemic index diets in type two diabetic subjects treated with oral agents

ISRCTN	ISRCTN36443696
DOI	https://doi.org/10.1186/ISRCTN36443696
Protocol serial number	MCT 67894
Sponsor	Canadian Institutes of Health Research (CIHR) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT 67894)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Cyril W C Kendall
Scientific

University of Toronto
Department of Nutritional Sciences
Faculty of Medicine
150 College Street
Room 340
Toronto, ON
M5S 3E2
Canada

Email	cyril.kendall@utoronto.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Low glycemic index diets will improve glycemic control in type two diabetic subjects treated with oral agents.
Ethics approval(s)	Approval received from: 1. St. Michael's Hospital REB (ref: 04-021c) 2. University of Toronto REB (ref: 17914) As of 20/08/2007: The sample size was approved to be increased to 200 subjects by St. Michael's Hospital Ethics Board on 31 October 2006 (REB#04-021).
Health condition(s) or problem(s) studied	Type two Diabetes
Intervention	Control: Advice to consume a high cereal fibre, whole grain, normal Glycemic Index (GI) diet (mean GI = 80). Test: Advice to consume a low glycemic index diet (mean GI less than 70) based on differences in the particle size and nature of the study foods but with similar fibre content to the 'control diet'. For further information, please contact the principal investigator Dr David Jenkins or the principal co-investigator Dr Cyril Kendall at the address listed below.
Intervention type	Other
Primary outcome measure(s)	Treatment difference in the change in HbA1c accross treatments.
Key secondary outcome measure(s)	1. Fasting blood glucose 2. Fasting insulin 3. High sensitivity C-Reactive Protein (hs-CRP) 4. Oxidized Low Density Lipoprotein (LDL) 5. LDL particle size 6. High Density Lipoprotein (HDL) 7. Change in body weight or oral hypoglycemic agents
Completion date	01/06/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	144
Key inclusion criteria	1. Men and postmenopausal women with type two diabetes, greater than or equal to 18 years old 2. On oral hypoglycemic agents 3. Have fasting plasma HbA1c concentrations between 6.5 and 8.0%
Key exclusion criteria	1. Diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease or Coronary Heart Disease (CHD) (major coronary event) 2. Major surgery less than six months prior to randomisation, treatment with insulin, acarbose, steroids, or having serum triglycerides more than or equal to 4.0 mmol/L
Date of first enrolment	01/09/2004
Date of final enrolment	01/06/2007

University of Toronto

Toronto, ON
M5S 3E2
Canada

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