Canadian Trial of Dietary Carbohydrates in Diabetes

Study Overview
=================
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 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

Official Title
-----------------
Long-Term Effect of Altering the Source or Amount of Dietary Carbohydrate in Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Control - high carbohydrate, high glycemic index foods
* Drug: high carbohydrate, low glycemic index foods
* Drug: low carbohydrate, high monounsaturate fat foods


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Control - high carbohydrate, high glycemic index foods|nan|
|Drug: high carbohydrate, low glycemic index foods|nan|
|Drug: low carbohydrate, high monounsaturate fat foods|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  |  | 
| waist circumference |  |  | 
| occurrence of diet failure |  |  | 
| fasting glucose |  |  | 
| fasting C-reactive protein |  |  | 
| fasting lipids (total, HDL and LDL cholesterol and triglcyerides) |  |  | 
| fasting apolipoproteins A1 and B100 |  |  | 
| fasting free fatty acids |  |  | 
| fasting short chain fatty acids |  |  | 
| plasma glucose and insulin 30, 60 and 120min after 75g oral glucose |  |  | 
| insulin sensitivity (HOMA) |  |  | 
| beta-cell function (30min-fasting insulin)/(30min-fasting glucose) |  |  | 
| metabolic profile (glucose, insulin, triglycerides and FFA during 8h profile) |  |  | 
| quality of life |  |  | 
| gastrointestinal symptoms |  |  | 
| diet satisfactio |  |  |