Canadian Trial of Dietary Carbohydrates in Diabetes

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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 glycated hemoglobin, reduced beta-cell function and insulin sensitivity and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate, low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves glycemic control and beta-cell function

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Toronto

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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