Magnetic Resonance Imaging of Vascular Function

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT02206919

Collaborator

Unity Health Toronto (Other)

Enrollment

Location

Study Details

Study Description

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 roles such as regulating blood flow. Diabetes is a risk factor for vascular dysfunction. Dysfunction may involve the smaller and/or larger blood vessels. Failure in the ability of large (conduit) blood vessels to control blood flow may be an early feature of atherosclerosis, a leading cause of stroke and heart attack. Measures of blood vessel dilation give an indication of the health of the vessel. Ultrasound and MRI can assess vascular function by measuring changes in blood vessel dilation. Diabetes may also affect tiny vessels in the kidney. These vessels become porous allowing albumin (a protein in the blood) to leak into the urine. The investigators can easily measure the presence of albumin in the urine.

This study aims to explore if MRI can demonstrate an association between vascular health in tiny and larger (conduit) blood vessels, by testing for an association between blood flow regulatory capacity of large vessels and presence of albumin in the urine.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Endothelial Dysfunction

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Magnetic Resonance Imaging of Vascular Function

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Nov 1, 2015

Outcome Measures

Primary Outcome Measures

Popliteal FMD MRI technique correlates with albuminuria in those with early diabetic disease [One year]
If this MRI technique is sensitive enough to demonstrate an association between flow mediated dilatation (FMD) of the popliteal artery and albuminuria, this will make a case for the use of the MRI technique in measuring effects of various interventions on vascular function.

Secondary Outcome Measures

Blood measures related to cardiovascular disease and renal function [One year]
Dietary risk factors related to chronic disease [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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 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 ( 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)