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Canadian Trial of Dietary Carbohydrates in Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223574
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Information provided by:
University of Toronto

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

Condition or disease Intervention/treatment Phase
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Long-Term Effect of Altering the Source or Amount of Dietary Carbohydrate in Type 2 Diabetes
Study Start Date : January 2002
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Carbohydrates




Primary Outcome Measures :
  1. glycated hemoglobin

Secondary Outcome Measures :
  1. Body weight
  2. waist circumference
  3. occurrence of diet failure
  4. fasting glucose
  5. fasting C-reactive protein
  6. fasting lipids (total, HDL and LDL cholesterol and triglcyerides)
  7. fasting apolipoproteins A1 and B100
  8. fasting free fatty acids
  9. fasting short chain fatty acids
  10. plasma glucose and insulin 30, 60 and 120min after 75g oral glucose
  11. insulin sensitivity (HOMA)
  12. beta-cell function (30min-fasting insulin)/(30min-fasting glucose)
  13. metabolic profile (glucose, insulin, triglycerides and FFA during 8h profile)
  14. quality of life
  15. gastrointestinal symptoms
  16. diet satisfactio


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223574


Locations
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Canada, Alberta
Clinical Trials Centre
Edmonton, Alberta, Canada, T6G 2C8
Canada, Ontario
St. Joseph's Health Centre
London, Ontario, Canada, N6G 2M3
St. Michael's Hosptial
Toronto, Ontario, Canada, M5B 1W8
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
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Principal Investigator: Thomas MS Wolever, MD, PhD University of Toronto/St. Michael's Hospital
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ClinicalTrials.gov Identifier: NCT00223574    
Other Study ID Numbers: 44205
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases