- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223574
Canadian Trial of Dietary Carbohydrates in Diabetes
September 21, 2005 updated by: University of Toronto
Long-Term Effect of Altering the Source or Amount of Dietary Carbohydrate in Type 2 Diabetes
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment
168
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2C8
- Clinical Trials Centre
-
-
Ontario
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London, Ontario, Canada, N6G 2M3
- St. Joseph's Health Centre
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hosptial
-
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Quebec
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Montreal, Quebec, Canada, H2W 1T8
- Hotel Dieu
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Universitaire de Sante de l'Estrie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
glycated hemoglobin
|
Secondary Outcome Measures
Outcome Measure |
---|
quality of life
|
Body weight
|
fasting glucose
|
waist circumference
|
occurrence of diet failure
|
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)
|
gastrointestinal symptoms
|
diet satisfactio
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas MS Wolever, MD, PhD, University of Toronto/St. Michael's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Study Completion
October 1, 2004
Study Registration Dates
First Submitted
September 20, 2005
First Submitted That Met QC Criteria
September 21, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
September 22, 2005
Last Update Submitted That Met QC Criteria
September 21, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 44205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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