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Home > Research > Clinical Trials > Low Glycemic Index Diet for Type 2 Diabetics. Clinical trial #NCT01063374
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Low Glycemic Index Diet for Type 2 Diabetics

Conditions Phase Intervention Type
  • Diabetes Type 2
Phase 2
Dietary Supplement
low glycemic diet instruction
Dietary Supplement
high cereal fibre diet instruction

View trial NCT01063374 on www.clinicaltrials.gov

7,977 PatientsLikeMe members may be eligible for this trial.

  • Show contact details

Contacts

Please use the information below to contact the trial coordinators.

    David JA Jenkins, MD
    416-867-7475
    NutritionProject@smh.toronto.on.ca Cyril Kendall, PhD
    416-978-6527
    cyril.kendall@utoronto.ca
×

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

Cyril Kendall, PhD
416-978-6527
cyril.kendall@utoronto.ca

Overall Contact Backup

David JA Jenkins, MD
416-867-7475
NutritionProject@smh.toronto.on.ca

Locations

  • Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
    Toronto, Ontario Canada
    (Recruiting)

    Contact info

    Sandy Mitchell
    416-867-7474
    mitchells@smh.toronto.on.ca
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario Canada
    (Active, not recruiting)

Learn more at ClinicalTrials.gov

◄ Back to list of trials

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