Low Glycemic Index Diet (With Canola Oil) for Type 2 Diabetics - Full Text View

Purpose

Healthy individuals with type 2 diabetes will receive intensive counseling on food selection to improve glucose control using either high cereal fiber dietary strategies or low glycemic index foods especially canola oil containing bread. The treatments will last 3 months with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or both diets, then use of high fiber, and/or low glycemic index foods with canola oil, may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.

Condition	Intervention	Phase
Type 2 Diabetes	Dietary Supplement: low glycemic index diet with canola oil bread Dietary Supplement: High fiber diet	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Low Glycemic Index Diets (With Canola Oil) on Glucose Control in Non-Insulin Dependent Diabetics

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Dietary Fiber

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:

Change in HbA1c [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]
change in serum lipids [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

fasting glucose [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]
change in weight, waist, and hip circumference [ Time Frame: weeks 0 to 12 ] [ Designated as safety issue: Yes ]
change in blood pressure [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]
creatinine, urea, and c-peptides in 24 hour urine collection [ Time Frame: 0, 12 weeks ] [ Designated as safety issue: Yes ]
endothelial function [ Time Frame: week 0, 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Low glycemic index diet with canola oil bread Subjects will given whole wheat bread which includes canola oil, and advised to follow a diabetic diet using low glycemic index foods.	Dietary Supplement: low glycemic index diet with canola oil bread
Active Comparator: high fiber diet Subjects will be given whole wheat bread, and advised to follow a healthy high fiber diabetic diet.	Dietary Supplement: High fiber diet

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Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women with type 2 diabetes who
- are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
- have a HbA1c in the range of 6.5 to 8.5% at the initial screening visit and at the prestudy visit (visit just prior to randomization)
- have diabetes diagnosed >6 months
- have maintained stable weight for 2 months (within 3%)
- have a valid OHIP card and a family physician
- if prescribed lipid medication, have taken a stable dose for at least 2 weeks
- if prescribed blood pressure medication, have taken a stable dose for at least 1 week
- can keep written food records, with the use of a digital scale

Exclusion Criteria: Individuals who

take insulin
take steroids
have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS)
have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months
take warfarin (Coumadin)
have had major surgery in the past 6 months
have a major debilitating disorder
have clinically significant liver disease (AST or ALT > 130 U/L), excluding NAFL or NASH
have hepatitis B or C
have renal failure (high creatinine > 150 mmol/L)
have serum triglycerides ≥ 6.0 mmol/L
have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
have food allergies to canola oil, study food components
have elevated blood pressure (> 145/90) unless approved by GP
have acute or chronic infections (bacterial or viral)
have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative colitis)
have other conditions which in the opinion of any of the investigators would make them unsuitable for the study
If HbA1c rises above 8.5% over two consecutive routine measurements, subjects will be referred back to their family doctors for an increase in anti hyperglycemic medications according to a predetermined protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348568

Locations

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C2T2

Sponsors and Collaborators

University of Toronto

Canola Council of Canada

Investigators

Principal Investigator:	David J A Jenkins, MD, DSc	Dept of Nutritional Science, University of Toronto, Toronto, ON, Canada
Principal Investigator:	Cyril W C Kendall, PhD	Dept of Nutritional Science, University of Toronto, Toronto, Canada
Principal Investigator:	Robert Josse, MD	Dept of Medicine, Div of Endocrinology and Metabolism, St. Michael's, Toronto, ON, Canada

More Information

No publications provided

Responsible Party:	David Jenkins, Principle Investigator, University of Toronto
ClinicalTrials.gov Identifier:	NCT01348568 History of Changes
Other Study ID Numbers:	09-191
Study First Received:	May 4, 2011
Last Updated:	January 17, 2013
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013