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

Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Low glycemic index diet with pulses; Dietary supplement: High Cereal Fibre

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in HbA1c	from prestudy and week 0, to end of treatment weeks 8, 10, and 12
serum lipids	from prestudy and week 0, to end of treatment weeks 8, 10, and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
fasting glucose	from prestudy and week 0, to end of treatment weeks 8, 10, and 12
change in weight, waist and hip circumference	weeks 0, 12
blood pressure	from prestudy and week 0, to end of treatment weeks 8, 10, and 12
creatine, urea, and c-peptides in 24 hour urine collection	0, 12 weeks.

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Saskatchewan Pulse Growers; Pulse Canada

Publications and helpful links

General Publications

• Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 3, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 5, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 09-192