<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/NCT01690481</url>
  </required_header>
  <id_info>
    <org_study_id>SU-09242009-4020</org_study_id>
    <secondary_id>IRB# 7723</secondary_id>
    <nct_id>NCT01690481</nct_id>
  </id_info>
  <brief_title>The Effects of High and Low Blood Glucose Values on the Brain in Children With Type 1 Diabetes Mellitus</brief_title>
  <official_title>Neurocognitive and Neuroanatomical Studies in Young Children With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>William E And Aenid R Weisgerber Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Simplified Brochure&#xD;
&#xD;
      Neuropsychological Testing/Assessment is like games for the child. They are asked to complete&#xD;
      the sequence, identify pictures, explain what is happening, etc. There is no personality&#xD;
      testing involved. Part of the standard IQ testing is done but no IQ score is obtained. Age&#xD;
      appropriate testing is done for each child.&#xD;
&#xD;
      The MRI is an enclosed machine. We have the child sit in a simulator after the&#xD;
      neuropsychological testing to see what it will be like, including the sounds, etc. You will&#xD;
      be given a video about MRI testing to view as well. The staff that does this has been doing&#xD;
      this for years in a wide variety of children, young, developmental delayed, etc. The staff&#xD;
      does this WITHOUT sedation. Some children cannot sit still through the entire series. We need&#xD;
      to get six, 10 minute scans. Children are allowed movement such as the need to wiggle their&#xD;
      toes and move in between each scan.&#xD;
&#xD;
      The Neuropsychological Testing can be scheduled in the late afternoons if it is more&#xD;
      convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled&#xD;
      after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked to&#xD;
      repeat the Neuropsychological Testing and MRI scanning 24 months later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BROCHURE:&#xD;
&#xD;
      Name of Study: Neuropsychological and Neuroanatomical Studies in Young Children Study&#xD;
      Directors: Tandy Aye, MD; Bruce Buckingham, MD; Darrell Wilson, MD&#xD;
&#xD;
      About the Study: This study is being conducted to see if Type 1 diabetes mellitus has any&#xD;
      affect on learning, behavior and development in young children. Fifty to 60 children between&#xD;
      the ages of 3 to less than 10 years with Type 1 diabetes mellitus will have&#xD;
      neuropsychological testing and a nonsedated MRI scan of the head performed. The study will&#xD;
      compare the results from those with diabetes to a control group of 20-30 children between the&#xD;
      ages of 3 to less than 10 years without Type 1 diabetes mellitus. The control subjects will&#xD;
      have neuropsychological testing and a nonsedated MRI scan of the head performed as well. All&#xD;
      subjects maybe asked to repeat the neuropsychological testing and nonsedated MRI scan of the&#xD;
      head 24 months later. The children with Type 1 diabetes mellitus will not have any changes&#xD;
      made to their current diabetes regimen. The children with Type 1 diabetes mellitus should&#xD;
      continue to check blood glucose values as required by their doctors and bring their meter(s)&#xD;
      for downloading to each visit. The child should also tell his/her doctor about the frequency&#xD;
      of severe low and high blood glucose values to his/er doctor as routinely asked.&#xD;
&#xD;
      Participant Schedule:&#xD;
&#xD;
        1. One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological&#xD;
           testing and to become familiar with the MRI scanner.&#xD;
&#xD;
        2. Subjects who need to become more familiar with the MRI scanning process will view a&#xD;
           video tape at home.&#xD;
&#xD;
        3. One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head&#xD;
           completed.&#xD;
&#xD;
        4. Subjects may have the neuropsychological testing and MRI scan repeated 24 months from&#xD;
           time of the initial testing and scan.&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
      To take part in the study, the child must meet the following inclusion criteria:&#xD;
&#xD;
        1. Be between the ages of 3 to 10 years.&#xD;
&#xD;
        2. Have been diagnosed with type 1 diabetes for at least 6 months.&#xD;
&#xD;
        3. Do not have plans to move out of the area within the next 36 months.&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
      A history of head trauma with any loss of consciousness cystic fibrosis prematurity (born&#xD;
      less than 30 weeks of gestation) significant developmental delay (lack of single word speech&#xD;
      or ability to walk independently by 18 months of age) neurologic disease independent of&#xD;
      diabetes (eg seizure disorder or medical contraindication to MRI procedure (eg metal&#xD;
      appliances such as braces).&#xD;
&#xD;
      Compensation: There will be no cost to the subjects to participate in this research study.&#xD;
      Participants will be compensated for their time. If you are interested in participating in&#xD;
      this study and you meet the inclusion criteria, please contact:&#xD;
&#xD;
      Kim Caswell, APRN, BC (650)-724-1201 Email: kcaswell@stanford.edu Tandy Aye, MD&#xD;
      (650)-723-5791 Email: taye@stanford.edu&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2006</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>MRI brain volumes</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological scores</measure>
    <time_frame>3 yr</time_frame>
    <description>FSIQ, Memory score, Verbal comprehension score</description>
  </secondary_outcome>
  <enrollment type="Actual">43</enrollment>
  <condition>Diabetes Mellitus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children between ages 3 to 10 with and without type 1 diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To take part in the study, you or your child must meet the following inclusion&#xD;
             criteria:&#xD;
&#xD;
               -  Be between the ages of 3 to 10 years.&#xD;
&#xD;
               -  Have been diagnosed with type 1 diabetes for at least 6 months.&#xD;
&#xD;
               -  Do not have plans to move out of the area within the next 36 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        If the interested participant has a history of:&#xD;
&#xD;
          -  head trauma with any loss of consciousness,&#xD;
&#xD;
          -  cystic fibrosis,&#xD;
&#xD;
          -  prematurity (born less than 30 weeks of gestation),&#xD;
&#xD;
          -  significant developmental delay (lack of single word speech or ability to walk&#xD;
             independently by 18 months of age),&#xD;
&#xD;
          -  neurologic disease independent of diabetes (eg seizure disorder or medical&#xD;
             contraindication to MRI procedure (eg metal appliances such as braces)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tandy Aye MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>April 13, 2016</last_update_submitted>
  <last_update_submitted_qc>April 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Tandy Aye</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <!-- 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/NCT01690481
org study id: SU-09242009-4020
secondary id: IRB# 7723
nct id: NCT01690481
lead sponsor: 
collaborator: 
has dmc: No
Simplified Brochure

      Neuropsychological Testing/Assessment is like games for the child. They are asked to complete
      the sequence, identify pictures, explain what is happening, etc. There is no personality
      testing involved. Part of the standard IQ testing is done but no IQ score is obtained. Age
      appropriate testing is done for each child.

      The MRI is an enclosed machine. We have the child sit in a simulator after the
      neuropsychological testing to see what it will be like, including the sounds, etc. You will
      be given a video about MRI testing to view as well. The staff that does this has been doing
      this for years in a wide variety of children, young, developmental delayed, etc. The staff
      does this WITHOUT sedation. Some children cannot sit still through the entire series. We need
      to get six, 10 minute scans. Children are allowed movement such as the need to wiggle their
      toes and move in between each scan.

      The Neuropsychological Testing can be scheduled in the late afternoons if it is more
      convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled
      after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked to
      repeat the Neuropsychological Testing and MRI scanning 24 months later.
BROCHURE:

      Name of Study: Neuropsychological and Neuroanatomical Studies in Young Children Study
      Directors: Tandy Aye, MD; Bruce Buckingham, MD; Darrell Wilson, MD

      About the Study: This study is being conducted to see if Type 1 diabetes mellitus has any
      affect on learning, behavior and development in young children. Fifty to 60 children between
      the ages of 3 to less than 10 years with Type 1 diabetes mellitus will have
      neuropsychological testing and a nonsedated MRI scan of the head performed. The study will
      compare the results from those with diabetes to a control group of 20-30 children between the
      ages of 3 to less than 10 years without Type 1 diabetes mellitus. The control subjects will
      have neuropsychological testing and a nonsedated MRI scan of the head performed as well. All
      subjects maybe asked to repeat the neuropsychological testing and nonsedated MRI scan of the
      head 24 months later. The children with Type 1 diabetes mellitus will not have any changes
      made to their current diabetes regimen. The children with Type 1 diabetes mellitus should
      continue to check blood glucose values as required by their doctors and bring their meter(s)
      for downloading to each visit. The child should also tell his/her doctor about the frequency
      of severe low and high blood glucose values to his/er doctor as routinely asked.

      Participant Schedule:

        1. One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological
           testing and to become familiar with the MRI scanner.

        2. Subjects who need to become more familiar with the MRI scanning process will view a
           video tape at home.

        3. One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head
           completed.

        4. Subjects may have the neuropsychological testing and MRI scan repeated 24 months from
           time of the initial testing and scan.

      Inclusion Criteria:

      To take part in the study, the child must meet the following inclusion criteria:

        1. Be between the ages of 3 to 10 years.

        2. Have been diagnosed with type 1 diabetes for at least 6 months.

        3. Do not have plans to move out of the area within the next 36 months.

      Exclusion Criteria:

      A history of head trauma with any loss of consciousness cystic fibrosis prematurity (born
      less than 30 weeks of gestation) significant developmental delay (lack of single word speech
      or ability to walk independently by 18 months of age) neurologic disease independent of
      diabetes (eg seizure disorder or medical contraindication to MRI procedure (eg metal
      appliances such as braces).

      Compensation: There will be no cost to the subjects to participate in this research study.
      Participants will be compensated for their time. If you are interested in participating in
      this study and you meet the inclusion criteria, please contact:

      Kim Caswell, APRN, BC (650)-724-1201 Email: kcaswell@stanford.edu Tandy Aye, MD
      (650)-723-5791 Email: taye@stanford.edu
observational model: Cohort
time perspective: Prospective
measure: MRI brain volumes
time frame: 3 years
measure: Neuropsychological scores
time frame: 3 yr
description: FSIQ, Memory score, Verbal comprehension score
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tandy Aye MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Tandy Aye
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1