Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- University of Toronto
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- change in HbA1c
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
David Jenkins
Principle Investigator
University of Toronto
Eligibility 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
Outcomes
Primary Outcomes
change in HbA1c
Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
serum lipids
Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
Secondary Outcomes
- 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)