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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: High Cereal Fibre; Dietary Supplement: Low glycemic index diet with pulses

• Registration Number: NCT01063361
• Lead Sponsor: University of Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-05
• Primary Completion: 2011-08
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Cereal Fibre Diet	High Cereal Fibre	-
Low glycemic Index Diet	Low glycemic index diet with pulses	Low glycemic Index Diet, emphasizing pulses

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada