Clinical trial NCT00223574: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 168
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: glycated hemoglobin
Secondary outcomes:
measure: Body weight
measure: waist circumference
measure: occurrence of diet failure
measure: fasting glucose
measure: fasting C-reactive protein
measure: fasting lipids (total, HDL and LDL cholesterol and triglcyerides)
measure: fasting apolipoproteins A1 and B100
measure: fasting free fatty acids
measure: fasting short chain fatty acids
measure: plasma glucose and insulin 30, 60 and 120min after 75g oral glucose
measure: insulin sensitivity (HOMA)
measure: beta-cell function (30min-fasting insulin)/(30min-fasting glucose)
measure: metabolic profile (glucose, insulin, triglycerides and FFA during 8h profile)
measure: quality of life
measure: gastrointestinal symptoms
measure: diet satisfactio
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Clinical Trials Centre
state: Alberta
city: London
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hosptial
state: Ontario
city: Montreal
country: Canada
facility: Hotel Dieu
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Universitaire de Sante de l'estrie
state: Quebec
Study officials:
affiliation: University of Toronto/St. Michael's Hospital
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: