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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Low glycemic index diet with pulses
* Dietary Supplement: High Cereal Fibre


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low glycemic Index Diet<br>Low glycemic Index Diet, emphasizing pulses | Dietary Supplement: Low glycemic index diet with pulses<br>* Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.<br>|
| Active Comparator: High Cereal Fibre Diet<br> | Dietary Supplement: High Cereal Fibre<br>* Subjects will be advised to follow a healthy high fibre diabetic diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. |