Canadian Trial of Dietary Carbohydrates in Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223574
• Other study ID #: 44205
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: September 21, 2005
• Start date: January 2002
• Est. completion date: October 2004

Study information

• Verified date: September 2005
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Control - high carbohydrate, high glycemic index foods

• high carbohydrate, low glycemic index foods

• low carbohydrate, high monounsaturate fat foods

Locations

Country	Name	City	State
Canada	Clinical Trials Centre	Edmonton	Alberta
Canada	St. Joseph's Health Centre	London	Ontario
Canada	Hotel Dieu	Montreal	Quebec
Canada	Centre Universitaire de Sante de l'estrie	Sherbrooke	Quebec
Canada	St. Michael's Hosptial	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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