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Canadian Trial of Dietary Carbohydrates in Diabetes

NCT ID: NCT00223574

Last Updated: 2005-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Control - high carbohydrate, high glycemic index foods

Intervention Type DRUG

high carbohydrate, low glycemic index foods

Intervention Type DRUG

low carbohydrate, high monounsaturate fat foods

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Thomas MS Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto/St. Michael's Hospital

Locations

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Clinical Trials Centre

Edmonton, Alberta, Canada

Site Status

St. Joseph's Health Centre

London, Ontario, Canada

Site Status

St. Michael's Hosptial

Toronto, Ontario, Canada

Site Status

Hotel Dieu

Montreal, Quebec, Canada

Site Status

Centre Universitaire de Sante de l'estrie

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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44205

Identifier Type: -

Identifier Source: org_study_id