Low Glycemic Index Diets (With Pulses) in Type 2 Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.]
Eligibility Criteria
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
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have a HbA1c in the range of 6.5% to 8.5% at screening and at the visit prior to randomization
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have diabetes diagnosed >6 months
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have maintained stable weight for 2 months (within 3%)
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have a valid OHIP card and a family physician
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if prescribed lipid medication, have taken a stable dose for at least 2 weeks
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if prescribed blood pressure medication, have taken a stable dose for at least 1 week
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can keep written food records, with the use of a digital scale
Exclusion Criteria: Individuals who
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take insulin
-
take steroids
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have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS)
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have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months
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take warfarin (Coumadin)
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have had major surgery in the past 6 months
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have a major debilitating disorder
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have clinically significant liver disease (AST or ALT > 130 U/L), excluding NAFL or NASH
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have hepatitis B or C
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have renal failure (high creatinine > 150 mmol/L)
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have serum triglycerides ≥ 6.0 mmol/L
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have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
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have food allergies to study food components
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have elevated blood pressure (> 145/90) unless approved by GP
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have acute or chronic infections (bacterial or viral)
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have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative colitis)
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have other conditions which in the opinion of any of the investigators would make them unsuitable for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
Sponsors and Collaborators
- University of Toronto
- Saskatchewan Pulse Growers
- Pulse Canada
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09-192