NCT01063374

Low Glycemic Index Diet for Type 2 Diabetics

Low Glycemic Index Diets to Improve Glycemic Control and Cardiovascular Disease in Type 2 Diabetics

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A low glycemic index diet may improve glycemic control and reduce plaque buildup in arteries of those with type 2 diabetes. Subjects will be randomly assigned to receive dietary advice on either a low glycemic index diet, or a high cereal fibre diet, for three years.

Detailed description

All subjects will be randomized to one 3-year treatment in a two-treatment parallel design. Treatments: 1. low glycemic index dietary advice (e.g. to eat intact grain cereals, parboiled rice, cracked wheat, pasta, peas, beans, lentils, and baked goods made from legume flour); or 2. a high cereal fiber diet emphasizing whole grains. Duration: The study will consist of approximately two months of recruitment and patient selection, during which time estimation of individual caloric requirements will be assessed, and a 3 year treatment period assigned. Study Details: Fasting blood samples are obtained at screening, week -2, and months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 each study period. HbA1c will be assessed on all visits. A carotid ultrasound (CUS) (screening, months 0, 12 and 36) and magnetic resonance imaging (MRI) (months 0, 12 and 36) technologies will be used to assess arterial wall thickening and changes in the nature of carotid plaques. Twenty-four hour urine for urinary C-peptide analyses will be obtained immediately prior to the beginning of the study and at the end of each 3 year treatment phase. At the end of the 3 year treatment period, subjects who wish to undertake the alternate treatment will be given appropriate instruction.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	low glycemic diet instruction
DIETARY_SUPPLEMENT	high cereal fibre diet instruction

Timeline

• Start date: 2010-03-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2010-02-05
• Last updated: 2016-09-14

Locations

2 sites across 1 country: Canada