<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/NCT04455867</url>
  </required_header>
  <id_info>
    <org_study_id>422-2015</org_study_id>
    <secondary_id>0939</secondary_id>
    <nct_id>NCT04455867</nct_id>
  </id_info>
  <brief_title>The Sunnybrook Type 2 Diabetes Study</brief_title>
  <acronym>S2DS</acronym>
  <official_title>The Sunnybrook Type 2 Diabetes Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Sunnybrook Type 2 Diabetes Study (S2DS) is a prospective observational study of people&#xD;
      with prediabetes or Type 2 Diabetes Mellitus (T2DM), that aims to understand the aetiologies,&#xD;
      manifestations, and clinical consequences of mood and cognitive complications. The study&#xD;
      recruits from the services at Sunnybrook Health Sciences Centre and from the neighbouring&#xD;
      University Health Network Toronto Rehabilitation Institute Cardiac Rehabilitation Program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The S2DS is a prospective observational study of people with prediabetes or T2DM recruited&#xD;
      from Sunnybrook Health Sciences Centre and the neighbouring University Health Network Toronto&#xD;
      Rehabilitation Institute Cardiac Rehabilitation Program. Participants recruited from&#xD;
      Sunnybrook are receiving care from services there (e.g. Family Medicine, Endocrinology, and&#xD;
      the Sunnybrook Diabetes Education Centre). Participants recruited from the Toronto Rehab are&#xD;
      undertaking a 6-month stepped hybrid (home and clinic based) aerobic plus resistance exercise&#xD;
      intervention as part of a program at that site (e.g. the Diabetes, Exercise, and Healthy&#xD;
      Lifestyle Program).&#xD;
&#xD;
      Study assessments are conducted at baseline, 3 months, 6 months and 18 months. Main outcomes&#xD;
      include cognitive performance, assessed using a detailed neurocognitive battery, and mood&#xD;
      symptoms assessed via research criteria for a depressive episode and self-report instruments.&#xD;
      Other lifestyle factors are also examined, including physical activity, sleep quality, diet,&#xD;
      and subjective stress. Diabetes complications and characteristics are monitored, as are all&#xD;
      concomitant medications and supplements. With permission, participant data are linked&#xD;
      prospectively to public health records to ascertain long-term outcomes and health services&#xD;
      utilization.&#xD;
&#xD;
      The cohort is characterized using biological, neuroimaging and biometric measures. Fasting&#xD;
      morning blood and urine samples are taken at each assessment. Serum, plasma, whole blood, and&#xD;
      white blood cells are bio-banked for biochemical, genetic and other analyses. The MRI study&#xD;
      includes a 1.5 hr MRI scan at 3.0 T. Sequences performed include structural imaging (T1, T2,&#xD;
      DTI and FLAIR) and resting state functional MRI. Two optional sub-studies are offered: a&#xD;
      cerebrovascular reactivity MRI protocol, and a sleep quality and apnea protocol (baseline, 6&#xD;
      month and 18 month visits). The sleep study uses an overnight wearable sleep monitor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>18 Months</target_duration>
  <primary_outcome>
    <measure>Depressive episode</measure>
    <time_frame>6 Months</time_frame>
    <description>Depressive episodes are identified using a Structured Clinical Interview for the DSM-5 criteria (SCID-5RV).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropsychological function</measure>
    <time_frame>6 Months</time_frame>
    <description>A Z-score computed from a sensitive neuropsychological battery is administered based on the Canadian Stroke Network &amp; National Institutes of Neurological Disorders recommendations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>Baseline, 3 Month, 6 Month, 18 Month</time_frame>
    <description>Depressive symptoms are monitored using the Beck Depression Inventory-II (BDI-II).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Status</measure>
    <time_frame>Baseline, 3 Month, 6 Month, 18 Month</time_frame>
    <description>Cognitive status is monitored using the Montreal Cognitive Assessment (MoCA).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>UHN Toronto Rehab</arm_group_label>
    <description>Participants with prediabetes of T2DM undertaking a 6-month stepped hybrid (home and clinic based) aerobic plus resistance exercise intervention as per the site's standard protocol (Diabetes Exercise and Healthy Lifestyle Program).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sunnybrook Health Sciences Centre</arm_group_label>
    <description>Participants with prediabetes or T2DM receiving care from an outpatient service at Sunnybrook Health Sciences Centre.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes Exercise and Healthy Lifestyle Program</intervention_name>
    <description>The program combines exercise, education and healthy lifestyle behaviour changes. Participants will begin the program with a cardiopulmonary exercise assessment. Then the team will create a personalized program of exercise based on functional abilities and personal goals. Participants will attend 1 supervised exercise class a week, which includes a warm-up and stretching routine, aerobic exercise (walking, stationary cycling or elliptical machine), resistance training and an educational session. This program also offers peer-to-peer support and encourages participants to carry out their own exercise program at home 4 more times per week and to keep a weekly exercise diary to help them with their progress.</description>
    <arm_group_label>UHN Toronto Rehab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Outpatient care</intervention_name>
    <description>Participants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education</description>
    <arm_group_label>Sunnybrook Health Sciences Centre</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum Plasma White blood cells Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of individuals with prediabetes or T2DM who are receiving&#xD;
        care from an outpatient service at Sunnybrook Health Sciences Centre, or as part of the&#xD;
        Diabetes and Healthy Lifestyle Program at the University Health Network Toronto&#xD;
        Rehabilitation Institute Cardiac Rehabilitation Program.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have at least one of the following: high HbA1c, impaired fasting glucose (IFG),&#xD;
             impaired glucose tolerance (IGT), but not yet diagnosed with Type 2 diabetes or have a&#xD;
             diagnosis of Type 2 diabetes.&#xD;
&#xD;
          -  Be able to communicate in English&#xD;
&#xD;
          -  Be 18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Current cancer diagnosis&#xD;
&#xD;
          -  Have a prior diagnosis of bipolar disorder or schizophrenia.&#xD;
&#xD;
          -  Have a prior diagnosis of a neurological and/or neurodegenerative disorder.&#xD;
&#xD;
          -  Have a current substance use disorder or a previous substance use disorder diagnosed&#xD;
             within the last 5 years (excluding nicotine)&#xD;
&#xD;
          -  Poor score on the Mini Mental State Examination (MMSE)&#xD;
&#xD;
        Exclusion criteria (Brain Imaging Sub-Study):&#xD;
&#xD;
          -  Contraindications to SHSC's MRI safety protocol.&#xD;
&#xD;
          -  Participants that do not meet the inclusion/exclusion criteria of the main study.&#xD;
&#xD;
        Exclusion criteria for (Brain Imaging Sub-Study - CVR procedure):&#xD;
&#xD;
          -  Use of medical equipment that would interfere with the placement of the CVR mask.&#xD;
&#xD;
          -  Significant pulmonary disease (e.g. asthma, pulmonary fibrosis, emphysema, chronic&#xD;
             obstructive pulmonary disease, pulmonary vascular disease, pleural disorders,&#xD;
             pneumonia)&#xD;
&#xD;
          -  Participants that do not meet the criteria for the MRI sub-study.&#xD;
&#xD;
        Exclusion criteria (Sleep Quality and Apnea Sub-Study):&#xD;
&#xD;
          -  Participants that have a medical device that would interfere with placement of&#xD;
             portable sleep monitor equipment i.e. Participant requires O2 therapy and uses nasal&#xD;
             prongs&#xD;
&#xD;
          -  Participants that have a condition that may compromise accuracy of the HSAT results&#xD;
             i.e. moderate-severe pulmonary disease or congestive heart failure&#xD;
&#xD;
          -  Participants that do not meet the inclusion/exclusion criteria of the main study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walter Swardfager, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Walter Swardfager, PhD</last_name>
    <phone>416-480-6100</phone>
    <phone_ext>85409</phone_ext>
    <email>w.swardfager@utoronto.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chelsi Major-Orfao, MEd</last_name>
    <phone>416-480-6100</phone>
    <phone_ext>85404</phone_ext>
    <email>chelsi.major-orfao@sri.utoronto.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sunnybrook Research Institute</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walter Swardfager, PhD</last_name>
      <phone>416-480-6100</phone>
      <email>w.swardfager@utoronto.ca</email>
    </contact>
    <contact_backup>
      <last_name>Chelsi Major-Orfao, MEd</last_name>
      <phone>416-480-6100</phone>
      <phone_ext>85404</phone_ext>
      <email>chelsi.major-orfao@sri.utoronto.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Walter Swardfager, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul I Oh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Krista L Lanctot, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Baiju R Shah, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jane Mitchell, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nathan Herrmann, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sandra E Black, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pearl Yang, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bradley J MacIntosh, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexander Kiss, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark I Boulos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jaan Reitav, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeremy Gilbert, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ilana J Halperin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Angela Assal, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Lim, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jennifer S Rabin, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maged Goubran, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ana C Andreazza, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Walter Swardfager</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Mood</keyword>
  <keyword>Cognition</keyword>
  <keyword>Brain Imaging</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Sleep</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04455867
org study id: 422-2015
secondary id: 0939
nct id: NCT04455867
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Sunnybrook Type 2 Diabetes Study (S2DS) is a prospective observational study of people
      with prediabetes or Type 2 Diabetes Mellitus (T2DM), that aims to understand the aetiologies,
      manifestations, and clinical consequences of mood and cognitive complications. The study
      recruits from the services at Sunnybrook Health Sciences Centre and from the neighbouring
      University Health Network Toronto Rehabilitation Institute Cardiac Rehabilitation Program.
The S2DS is a prospective observational study of people with prediabetes or T2DM recruited
      from Sunnybrook Health Sciences Centre and the neighbouring University Health Network Toronto
      Rehabilitation Institute Cardiac Rehabilitation Program. Participants recruited from
      Sunnybrook are receiving care from services there (e.g. Family Medicine, Endocrinology, and
      the Sunnybrook Diabetes Education Centre). Participants recruited from the Toronto Rehab are
      undertaking a 6-month stepped hybrid (home and clinic based) aerobic plus resistance exercise
      intervention as part of a program at that site (e.g. the Diabetes, Exercise, and Healthy
      Lifestyle Program).

      Study assessments are conducted at baseline, 3 months, 6 months and 18 months. Main outcomes
      include cognitive performance, assessed using a detailed neurocognitive battery, and mood
      symptoms assessed via research criteria for a depressive episode and self-report instruments.
      Other lifestyle factors are also examined, including physical activity, sleep quality, diet,
      and subjective stress. Diabetes complications and characteristics are monitored, as are all
      concomitant medications and supplements. With permission, participant data are linked
      prospectively to public health records to ascertain long-term outcomes and health services
      utilization.

      The cohort is characterized using biological, neuroimaging and biometric measures. Fasting
      morning blood and urine samples are taken at each assessment. Serum, plasma, whole blood, and
      white blood cells are bio-banked for biochemical, genetic and other analyses. The MRI study
      includes a 1.5 hr MRI scan at 3.0 T. Sequences performed include structural imaging (T1, T2,
      DTI and FLAIR) and resting state functional MRI. Two optional sub-studies are offered: a
      cerebrovascular reactivity MRI protocol, and a sleep quality and apnea protocol (baseline, 6
      month and 18 month visits). The sleep study uses an overnight wearable sleep monitor.
observational model: Cohort
time perspective: Prospective
measure: Depressive episode
time frame: 6 Months
description: Depressive episodes are identified using a Structured Clinical Interview for the DSM-5 criteria (SCID-5RV).
measure: Neuropsychological function
time frame: 6 Months
description: A Z-score computed from a sensitive neuropsychological battery is administered based on the Canadian Stroke Network & National Institutes of Neurological Disorders recommendations.
measure: Depressive symptoms
time frame: Baseline, 3 Month, 6 Month, 18 Month
description: Depressive symptoms are monitored using the Beck Depression Inventory-II (BDI-II).
measure: Cognitive Status
time frame: Baseline, 3 Month, 6 Month, 18 Month
description: Cognitive status is monitored using the Montreal Cognitive Assessment (MoCA).
arm group label: UHN Toronto Rehab
description: Participants with prediabetes of T2DM undertaking a 6-month stepped hybrid (home and clinic based) aerobic plus resistance exercise intervention as per the site's standard protocol (Diabetes Exercise and Healthy Lifestyle Program).
arm group label: Sunnybrook Health Sciences Centre
description: Participants with prediabetes or T2DM receiving care from an outpatient service at Sunnybrook Health Sciences Centre.
intervention type: Behavioral
intervention name: Diabetes Exercise and Healthy Lifestyle Program
description: The program combines exercise, education and healthy lifestyle behaviour changes. Participants will begin the program with a cardiopulmonary exercise assessment. Then the team will create a personalized program of exercise based on functional abilities and personal goals. Participants will attend 1 supervised exercise class a week, which includes a warm-up and stretching routine, aerobic exercise (walking, stationary cycling or elliptical machine), resistance training and an educational session. This program also offers peer-to-peer support and encourages participants to carry out their own exercise program at home 4 more times per week and to keep a weekly exercise diary to help them with their progress.
arm group label: UHN Toronto Rehab
intervention type: Other
intervention name: Outpatient care
description: Participants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education
arm group label: Sunnybrook Health Sciences Centre
Serum Plasma White blood cells Urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Walter Swardfager, PhD
role: Principal Investigator
affiliation: Sunnybrook Research Institute
last name: Walter Swardfager, PhD
phone: 416-480-6100
phone ext: 85409
email: w.swardfager@utoronto.ca
last name: Chelsi Major-Orfao, MEd
phone: 416-480-6100
phone ext: 85404
email: chelsi.major-orfao@sri.utoronto.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Walter Swardfager
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No