Canadian Trial of Dietary Carbohydrates in Diabetes

University of Toronto

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Drug: low carbohydrate, high monounsaturate fat foods

Drug: high carbohydrate, low glycemic index foods

Drug: Control - high carbohydrate, high glycemic index foods

Study type

Interventional

Funder types

Other

Identifiers

NCT00223574

44205

Details and patient eligibility

About

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

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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