Canadian Trial of Dietary Carbohydrates in Diabetes - Full Text View

Purpose

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

Condition	Intervention
Type 2 Diabetes	Drug: Control - high carbohydrate, high glycemic index foods Drug: high carbohydrate, low glycemic index foods Drug: low carbohydrate, high monounsaturate fat foods

MedlinePlus related topics:

Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Toronto:

Primary Outcome Measures:

glycated hemoglobin

Secondary Outcome Measures:

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

Estimated Enrollment:	168
Study Start Date:	January 2002
Estimated Study Completion Date:	October 2004

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223574

Locations


Canada, Alberta
	Clinical Trials Centre
	Edmonton, Alberta, Canada, T6G 2C8

Canada, Ontario
	St. Michael's Hosptial
	Toronto, Ontario, Canada, M5B 1W8
	St. Joseph's Health Centre
	London, Ontario, Canada, N6G 2M3

Canada, Quebec
	Hotel Dieu
	Montreal, Quebec, Canada, H2W 1T8
	Centre Universitaire de Sante de l'estrie
	Sherbrooke, Quebec, Canada, J1H 5N4

Sponsors and Collaborators

University of Toronto

Investigators


Principal Investigator:	Thomas MS Wolever, MD, PhD	University of Toronto/St. Michael's Hospital

More Information

Study ID Numbers:	44205
First Received:	September 20, 2005
Last Updated:	September 21, 2005
ClinicalTrials.gov Identifier:	NCT00223574
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	University of Toronto
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00223574