Status:
COMPLETED
Canadian Trial of Dietary Carbohydrates in Diabetes
Lead Sponsor:
University of Toronto
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate, low glycemic index diet, results in more rapid progression of diabetes; i.e. increased fasting glucose and...
Eligibility Criteria
Inclusion
- male or non-pregnant/non-lactating females with type 2 diabetes treated by diet alone
- age 53-75y
- body mass index 25-40kg/m\^2 (Caucasian) or 23-40kg/m\^2 (other)
- HbA1c \<=130% of upper limit of normal of local hospital lab
Exclusion
- use of any hypoglycemic or anti-hyperglycemic drug within 6 months of randomization
- major cardiovascular event or major surgery within 6 months of randomization
- serum triglycerides \>10mmol/L
- presence of other major debilitating disorder such as liver disease, renal failure or cancer
- presence of gastrointestinal disorder or use of drug which is likely to alter gastrointestinal motility or nutrient absorption
- use of oral steroids
- substance or alcohol abuse
- simultaneous participation in another clinical trial
- allergy or intolerance to more than one of wheat, barley, corn, oats, potato, legumes, nuts, psyllium, olives, avocado or canola
- unwilling or unable to follow the protocol and/or give informed consent
- subjects planning to be on holiday for more than 8 weeks in a row or a total of 12 weeks in the year in locations to which they will not take study food
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00223574
Start Date
January 1 2002
End Date
October 1 2004
Last Update
September 22 2005
Active Locations (5)
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1
Clinical Trials Centre
Edmonton, Alberta, Canada, T6G 2C8
2
St. Joseph's Health Centre
London, Ontario, Canada, N6G 2M3
3
St. Michael's Hosptial
Toronto, Ontario, Canada, M5B 1W8
4
Hotel Dieu
Montreal, Quebec, Canada, H2W 1T8