Back to resultsCanadian Trial of Dietary Carbohydrates in Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control - high carbohydrate, high glycemic index foods
high carbohydrate, low glycemic index foods
low carbohydrate, high monounsaturate fat foods
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
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
Sites / Locations
- Clinical Trials Centre
- St. Joseph's Health Centre
- St. Michael's Hosptial
- Hotel Dieu
- Centre Universitaire de Sante de l'estrie
Outcomes
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
Full Information
NCT ID
NCT00223574
First Posted
September 20, 2005
Last Updated
September 21, 2005
Sponsor
University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00223574
Brief Title
Canadian Trial of Dietary Carbohydrates in Diabetes
Official Title
Long-Term Effect of Altering the Source or Amount of Dietary Carbohydrate in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Toronto
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
168 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Control - high carbohydrate, high glycemic index foods
Intervention Type
Drug
Intervention Name(s)
high carbohydrate, low glycemic index foods
Intervention Type
Drug
Intervention Name(s)
low carbohydrate, high monounsaturate fat foods
Primary Outcome Measure Information:
Title
glycated hemoglobin
Secondary Outcome Measure Information:
Title
Body weight
Title
waist circumference
Title
occurrence of diet failure
Title
fasting glucose
Title
fasting C-reactive protein
Title
fasting lipids (total, HDL and LDL cholesterol and triglcyerides)
Title
fasting apolipoproteins A1 and B100
Title
fasting free fatty acids
Title
fasting short chain fatty acids
Title
plasma glucose and insulin 30, 60 and 120min after 75g oral glucose
Title
insulin sensitivity (HOMA)
Title
beta-cell function (30min-fasting insulin)/(30min-fasting glucose)
Title
metabolic profile (glucose, insulin, triglycerides and FFA during 8h profile)
Title
quality of life
Title
gastrointestinal symptoms
Title
diet satisfactio
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas MS Wolever, MD, PhD
Organizational Affiliation
University of Toronto/St. Michael's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
St. Joseph's Health Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2M3
Country
Canada
Facility Name
St. Michael's Hosptial
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Hotel Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Centre Universitaire de Sante de l'estrie
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Canadian Trial of Dietary Carbohydrates in Diabetes
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