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Low Glycemic Index Diets (With Pulses) in Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Saskatchewan Pulse Growers
Pulse Canada
Information provided by (Responsible Party):
David Jenkins, University of Toronto
ClinicalTrials.gov Identifier:
NCT01063361
First received: February 3, 2010
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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 emphasizing dried legumes and their products. 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 in the diet 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 pulses
Dietary Supplement: High Cereal Fibre
 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 Pulses) on Glucose Control in Non-Insulin Dependent Diabetics

Resource links provided by NLM:

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 ]
  • 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, 12 ] [ Designated as safety issue: Yes ]
  • blood pressure [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • creatine, urea, and c-peptides in 24 hour urine collection [ Time Frame: 0, 12 weeks. ] [ Designated as safety issue: Yes ]

Enrollment: 131
Study Start Date: February 2010
Estimated Study Completion Date: August 2015
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low glycemic Index Diet
Low glycemic Index Diet, emphasizing pulses
 Dietary Supplement: Low glycemic index diet with pulses
Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.
Active Comparator: High Cereal Fibre Diet Dietary Supplement: High Cereal Fibre
Subjects will be advised to follow a healthy high fibre diabetic diet.

  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 screening and at the visit 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063361

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
University of Toronto
Saskatchewan Pulse Growers
Pulse 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: NCT01063361     History of Changes
Other Study ID Numbers: 09-192
Study First Received: February 3, 2010
Last Updated: June 12, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013