Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT01348568
Eligibility Criteria:
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 8.5% at the initial screening visit and at the prestudy visit (visit just prior to randomization)
* 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 canola oil, study food components
* have elevated blood pressure (\> 145/90) unless approved by General Practitioner (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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01348568
Study Brief:
Protocol Section:
NCT01348568