DiabetesNCT02206919
Magnetic Resonance Imaging of Vascular Function
An observational study of Diabetes and Endothelial Dysfunction, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Endothelial Dysfunction
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men and women with type 2 diabetes
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
St Michael's Hospital
Toronto, Ontario, M5B 1W8
David Jenkins, MD, 4168677475, david.jenkins@utoronto.ca
Laura Chiavaroli, MSc., 4168677475, laura.chiavaroli@alumni.utoronto.ca
About this study
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.
- Conditions
- Diabetes, Endothelial Dysfunction
- Keywords
- Flow mediated dilation, Magnetic Resonance Imaging MRI, Diabetes, Endothelial dysfunction, Popliteal artery, Atherosclerosis, Cardiovascular disease, Vascular disease
- Medical subject headings
- Diabetes Mellitus, Atherosclerosis, Cardiovascular Diseases, Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Popliteal FMD MRI technique correlates with albuminuria in those with early diabetic disease
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.
Measured: One year
Secondary outcomes (2)
Blood measures related to cardiovascular disease and renal function
Measured: One year
Dietary risk factors related to chronic disease
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Dr. Alan Moody, Sunnybrook Health Sciences Centre
- Investigators
- Alan Moody, DR, Principal investigator, Sunnybrook Health Sciences CentreDavid Jenkins, DR, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206919
- Sponsor's protocol ID
- 066-2013
- Status last verified
- Jul 2014
- First submitted
- 30 Jul 2014
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Vascular Function
- ClinicalTrials.gov ID
- NCT02206919
- Acronym / sponsor ID
- 066-2013
- Conditions
- Diabetes, Endothelial Dysfunction
- Keywords
- Flow mediated dilation, Magnetic Resonance Imaging MRI, Diabetes, Endothelial dysfunction, Popliteal artery, Atherosclerosis, Cardiovascular disease, Vascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- Jun 2014
- Primary completion
- Nov 2015 (estimated)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men and women with type 2 diabetes
Key inclusion criteria (9 listed)
- Men and women with type 2 diabetes who:
Key exclusion criteria (18 listed)
- Individuals who
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Popliteal FMD MRI technique correlates with albuminuria in those with early diabetic disease
Time frame: 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.
2 secondary outcomes
Blood measures related to cardiovascular disease and renal function
Time frame: One year
Dietary risk factors related to chronic disease
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Moody, DR principal investigator
Sunnybrook Health Sciences Centre
David Jenkins, DR principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Endothelial Dysfunction, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan Moody, MD (4164806100 ext. 85432, alan.moody@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Popliteal FMD MRI technique correlates with albuminuria in those with early diabetic disease (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.