Status:
COMPLETED
Low Glycemic Index Diets vs. High Cereal Fibre Diets in Type 2 Diabetes
Lead Sponsor:
University of Toronto
Conditions:
Type 2 Diabetes
Cardiovascular Disease
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
Large observational studies have shown cereal fiber to protect from diabetes and heart disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers the glycemic index o...
Detailed Description
Recruitment: Subjects will be recruited by placing advertisements in local newspapers and by distributing similar advertisements to the diabetes clinic and diabetes education programs. Information Se...
Eligibility Criteria
Inclusion
- Men and postmenopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (Sulfonylureas, Biguanides, Thiazolidinediones , and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study
- HbA1c between 6.5 and 8.0% at recruitment
- living within a 40 km radius of St. Michael's Hospital
- Diabetes diagnosed \> 6 months prior to randomization
Exclusion
- diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease, or CHD (current clinically significant CHD e.g. unstable angina)
- taking insulin or acarbose
- smoking or significant alcohol intake (\> 1 drink/day)
- serum triglycerides \> 4.0 mmol/L
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00438698
Start Date
September 1 2004
End Date
June 1 2007
Last Update
December 16 2015
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2