Low Glycemic Index Diet for Type 2 Diabetics
| Conditions | Phase | Intervention Type |
|---|---|---|
| Phase 2 |
|
Eligibility
- Ages Eligible for Study
- 21 years and up
- Genders Eligible for Study
- Both
Keywords
Sponsors
- Other
- Canadian Institutes of Health Research (CIHR)
- Other
- University of Toronto
Inclusion Criteria
Men and women with type 2 diabetes who
- are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
- have a HbA1c in the range of 6.5 to 8.0% at screening and at the prestudy visit
- have diabetes diagnosed >6 months
- have maintained stable weight for 2 months (within 3%)
- have a valid OHIP card and a family physician
- if prescribed lipid medication, have taken a stable dose for at least 2 weeks
- if prescribed blood pressure medication, have taken a stable dose for at least 1 week
- can keep written food records, with the use of a digital scale
Exclusion Criteria
Individuals who
- take insulin
- take steroids
- have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease,
IBS)
- have had a major cardiovascular event (stroke or myocardial infarction) in the past 6
months
- take warfarin (Coumadin)
- have had major surgery in the past 6 months
- have a major debilitating disorder
- have clinically significant liver disease (AST or ALT > 130 U/L), excluding NAFL or
NASH
- have hepatitis B or C
- have renal failure (high creatinine > 150 mmol/L)
- have serum triglycerides ≥ 6.0 mmol/L
- have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
- have food allergies to study food components
- have elevated blood pressure (> 145/90) unless approved by GP
- have acute or chronic infections (bacterial or viral)
- have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative
colitis)
- have other conditions which in the opinion of any of the investigators would make
them unsuitable for the study
- If HbA1c rises above 8.5% over two consecutive routine measurements, subjects will be
referred back to their family doctors for an increase in anti hyperglycemic
medications according to a predetermined protocol.
- Any condition or circumstance which would prevent an individual from having an MRI
(e.g. individuals with prostheses or metal implants, or those who are excessively
claustrophobic)
Detailed Description
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063374
Overall Contact
Overall Contact Backup
Locations
-
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health CentreToronto, Ontario Canada(Recruiting)
Contact info
Sandy Mitchell416-867-7474mitchells@smh.toronto.on.ca -
Sunnybrook Health Sciences CentreToronto, Ontario Canada(Active, not recruiting)