<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02206919</url>
  </required_header>
  <id_info>
    <org_study_id>066-2013</org_study_id>
    <nct_id>NCT02206919</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging of Vascular Function</brief_title>
  <official_title>Magnetic Resonance Imaging of Vascular Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A major function of blood vessels is to control blood flow by dilating or constricting&#xD;
      depending on the demand. Vascular dysfunction is a state in which blood vessels fail to carry&#xD;
      out its normal roles such as regulating blood flow. Diabetes is a risk factor for vascular&#xD;
      dysfunction. Dysfunction may involve the smaller and/or larger blood vessels. Failure in the&#xD;
      ability of large (conduit) blood vessels to control blood flow may be an early feature of&#xD;
      atherosclerosis, a leading cause of stroke and heart attack. Measures of blood vessel&#xD;
      dilation give an indication of the health of the vessel. Ultrasound and MRI can assess&#xD;
      vascular function by measuring changes in blood vessel dilation. Diabetes may also affect&#xD;
      tiny vessels in the kidney. These vessels become porous allowing albumin (a protein in the&#xD;
      blood) to leak into the urine. The investigators can easily measure the presence of albumin&#xD;
      in the urine.&#xD;
&#xD;
      This study aims to explore if MRI can demonstrate an association between vascular health in&#xD;
      tiny and larger (conduit) blood vessels, by testing for an association between blood flow&#xD;
      regulatory capacity of large vessels and presence of albumin in the urine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <primary_completion_date type="Anticipated">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Popliteal FMD MRI technique correlates with albuminuria in those with early diabetic disease</measure>
    <time_frame>One year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood measures related to cardiovascular disease and renal function</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary risk factors related to chronic disease</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Diabetes</condition>
  <condition>Endothelial Dysfunction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women with type 2 diabetes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women with type 2 diabetes who:&#xD;
&#xD;
               -  are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks&#xD;
&#xD;
               -  have diabetes diagnosed &gt;6 months&#xD;
&#xD;
               -  have maintained stable weight for 2 months (within 3%)&#xD;
&#xD;
               -  have a valid Ontario Health Insurance Plan (OHIP) card and a family physician&#xD;
&#xD;
               -  if prescribed lipid medication, have taken a stable dose for at least 2 weeks&#xD;
&#xD;
               -  if prescribed blood pressure medication, have taken a stable dose for at least 1&#xD;
                  week&#xD;
&#xD;
               -  can keep written food records&#xD;
&#xD;
               -  carotid intima-media thickness (cIMT) &lt; 1.2 mm and ankle brachial index (ABI) of&#xD;
                  &gt;0.9.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who&#xD;
&#xD;
               -  take insulin&#xD;
&#xD;
               -  take steroids&#xD;
&#xD;
               -  have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's&#xD;
                  Disease, IBS)&#xD;
&#xD;
               -  have had a major cardiovascular event (stroke or myocardial infarction) in the&#xD;
                  past 6 months&#xD;
&#xD;
               -  take warfarin (Coumadin)&#xD;
&#xD;
               -  have had major surgery in the past 6 months&#xD;
&#xD;
               -  have a major debilitating disorder&#xD;
&#xD;
               -  have clinically significant liver disease ( liver transaminase levels &gt; 130 U/L),&#xD;
                  excluding Nonalcoholic fatty liver (NAFL) disease or NASH&#xD;
&#xD;
               -  have hepatitis B or C&#xD;
&#xD;
               -  have renal failure (high creatinine &gt; 150 mmol/L)&#xD;
&#xD;
               -  have serum triglycerides ≥ 6.0 mmol/L&#xD;
&#xD;
               -  have a history of cancer, except non-melanoma skin cancer (basal cell, squamous&#xD;
                  cell)&#xD;
&#xD;
               -  have food allergies to study food components&#xD;
&#xD;
               -  have acute or chronic infections (bacterial or viral)&#xD;
&#xD;
               -  have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative&#xD;
                  colitis)&#xD;
&#xD;
               -  have other conditions which in the opinion of any of the investigators would make&#xD;
                  them unsuitable for the study&#xD;
&#xD;
               -  Any condition or circumstance which would prevent an individual from having an&#xD;
                  MRI (e.g. individuals with prostheses or metal implants, or those who are&#xD;
                  excessively claustrophobic)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Moody, DR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Jenkins, DR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alan Moody, MD</last_name>
    <phone>4164806100</phone>
    <phone_ext>85432</phone_ext>
    <email>alan.moody@sunnybrook.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omodele Olowoyeye, MSc</last_name>
    <phone>4164806100</phone>
    <phone_ext>85463</phone_ext>
    <email>Omodele.Olowoyeye@sunnybrook.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>David Jenkins, MD</last_name>
      <phone>4168677475</phone>
      <email>david.jenkins@utoronto.ca</email>
    </contact>
    <contact_backup>
      <last_name>Laura Chiavaroli, MSc.</last_name>
      <phone>4168677475</phone>
      <email>laura.chiavaroli@alumni.utoronto.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Alan Moody</investigator_full_name>
    <investigator_title>Staff physician</investigator_title>
  </responsible_party>
  <keyword>Flow mediated dilation</keyword>
  <keyword>Magnetic Resonance Imaging MRI</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Endothelial dysfunction</keyword>
  <keyword>Popliteal artery</keyword>
  <keyword>Atherosclerosis</keyword>
  <keyword>Cardiovascular disease</keyword>
  <keyword>Vascular disease</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02206919
org study id: 066-2013
nct id: NCT02206919
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: Popliteal FMD MRI technique correlates with albuminuria in those with early diabetic disease
time frame: One year
description: 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.
measure: Blood measures related to cardiovascular disease and renal function
time frame: One year
measure: Dietary risk factors related to chronic disease
time frame: One year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alan Moody, DR
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Center
last name: David Jenkins, DR
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Alan Moody, MD
phone: 4164806100
phone ext: 85432
email: alan.moody@sunnybrook.ca
last name: Omodele Olowoyeye, MSc
phone: 4164806100
phone ext: 85463
email: Omodele.Olowoyeye@sunnybrook.ca
facility: 
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Alan Moody
investigator title: Staff physician