Status:
UNKNOWN
Magnetic Resonance Imaging of Vascular Function
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Unity Health Toronto
Conditions:
Diabetes
Endothelial Dysfunction
Eligibility:
All Genders
Brief Summary
A major function of blood vessels is to control blood flow by dilating or constricting depending on the demand. Vascular dysfunction is a state in which blood vessels fail to carry out its normal role...
Eligibility Criteria
Inclusion
- Men and women with type 2 diabetes who:
- are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
- have diabetes diagnosed \>6 months
- have maintained stable weight for 2 months (within 3%)
- have a valid Ontario Health Insurance Plan (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
- carotid intima-media thickness (cIMT) \< 1.2 mm and ankle brachial index (ABI) of \>0.9.
Exclusion
- 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 ( liver transaminase levels \> 130 U/L), excluding Nonalcoholic fatty liver (NAFL) disease 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 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
- 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)
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02206919
Start Date
June 1 2014
Last Update
August 1 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8