Low Glycemic Index Diet (With Canola Oil) for Type 2 Diabetics

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canola Council of Canada
Information provided by (Responsible Party):
David Jenkins, University of Toronto
ClinicalTrials.gov Identifier:
NCT01348568
First received: May 4, 2011
Last updated: May 23, 2013
Last verified: May 2013
  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:


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 ]
  • cancer cell proliferation (in vitro) [ Time Frame: week 0, 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
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 be 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

  Show Detailed Description

  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 General Practitioner (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: May 23, 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 September 18, 2014