Canadian Trial of Dietary Carbohydrates in Diabetes

NCT00223574 | Completed

• 1 other identifier: 44205
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 5

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• glycated hemoglobin

Secondary Outcomes (16)

• Body weight

• waist circumference

• occurrence of diet failure

• fasting glucose

• fasting C-reactive protein

Interventions

Control - high carbohydrate, high glycemic index foods DRUG

high carbohydrate, low glycemic index foods DRUG

low carbohydrate, high monounsaturate fat foods DRUG

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (5)

Clinical Trials Centre

Edmonton, Alberta, T6G 2C8, Canada

Location

St. Joseph's Health Centre

London, Ontario, N6G 2M3, Canada

Location

St. Michael's Hosptial

Toronto, Ontario, M5B 1W8, Canada

Location

Hotel Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Centre Universitaire de Sante de l'estrie

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thomas MS Wolever, MD, PhD

  University of Toronto/St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2002
• Study Completion: October 1, 2004
• Last Updated: September 22, 2005

Record last verified: 2005-09

Locations

CA (5)