<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/NCT03820349</url>
  </required_header>
  <id_info>
    <org_study_id>MED-2018-26438</org_study_id>
    <nct_id>NCT03820349</nct_id>
  </id_info>
  <brief_title>Cystic Fibrosis and Cognitive Function</brief_title>
  <official_title>Effects of Cystic Fibrosis and Cystic Fibrosis Related Diabetes on Brain Structure and Cognitive Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and&#xD;
      cystic fibrosis related diabetes (CFRD) on brain structure and function&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A growing body of evidence suggests that hyperglycemia in type 1 and type 2 diabetes is&#xD;
      associated with alterations in brain structure and cognitive impairment. People with cystic&#xD;
      fibrosis related diabetes (CRFD) are exposed to hyperglycemia as seen in other forms of&#xD;
      diabetes, and cystic fibrosis is also associated with chronic systemic inflammation. Both&#xD;
      hyperglycemia and chronic inflammation have been postulated to affect brain structure and&#xD;
      function. Cystic fibrosis trans-membrane conductance regulator (CFTR). protein is widely&#xD;
      expressed in the neurons of the brain including in the hippocampus The hippocampus plays an&#xD;
      essential role in learning and memory processing and is thought to be particularly vulnerable&#xD;
      to effects of metabolic stressors. The expression of CFTR in neurons has several potential&#xD;
      implications for central nervous system function, including cognition.&#xD;
&#xD;
      The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and&#xD;
      cystic fibrosis related diabetes (CFRD) on brain structure and function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2018</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">December 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MRI outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Measure the differences in the microstructure (fractional anisotropy) of hippocampus, comparing subjects with cystic fibrosis and healthy controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>baseline</time_frame>
    <description>Compare performance on neurocognitive function testing in subjects with cystic fibrosis and healthy controls. Multiple cognitive domains will be examined including intellectual function, processing speed. attention and memory.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Cystic Fibrosis</arm_group_label>
    <description>Subjects with cystic fibrosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <description>matched healthy controls</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Cystic Fibrosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        patients with Cystic fibrosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of stroke&#xD;
&#xD;
          -  History of epilepsy&#xD;
&#xD;
          -  History of neurosurgical procedures&#xD;
&#xD;
          -  Past or current history of severe psychiatric illness&#xD;
&#xD;
          -  Pass or current history of alcohol or substance abuse&#xD;
&#xD;
          -  Presence of metallic substances in body or inability to remove before imaging&#xD;
             procedure&#xD;
&#xD;
          -  History of claustrophobia or known inability to tolerate MRI&#xD;
&#xD;
          -  Current pregnancy&#xD;
&#xD;
          -  Inability to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>February 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CFRD</keyword>
  <keyword>Cystic fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT03820349
org study id: MED-2018-26438
nct id: NCT03820349
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and
      cystic fibrosis related diabetes (CFRD) on brain structure and function
A growing body of evidence suggests that hyperglycemia in type 1 and type 2 diabetes is
      associated with alterations in brain structure and cognitive impairment. People with cystic
      fibrosis related diabetes (CRFD) are exposed to hyperglycemia as seen in other forms of
      diabetes, and cystic fibrosis is also associated with chronic systemic inflammation. Both
      hyperglycemia and chronic inflammation have been postulated to affect brain structure and
      function. Cystic fibrosis trans-membrane conductance regulator (CFTR). protein is widely
      expressed in the neurons of the brain including in the hippocampus The hippocampus plays an
      essential role in learning and memory processing and is thought to be particularly vulnerable
      to effects of metabolic stressors. The expression of CFTR in neurons has several potential
      implications for central nervous system function, including cognition.

      The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and
      cystic fibrosis related diabetes (CFRD) on brain structure and function.
observational model: Case-Control
time perspective: Prospective
measure: MRI outcome
time frame: baseline
description: Measure the differences in the microstructure (fractional anisotropy) of hippocampus, comparing subjects with cystic fibrosis and healthy controls
measure: Cognitive function
time frame: baseline
description: Compare performance on neurocognitive function testing in subjects with cystic fibrosis and healthy controls. Multiple cognitive domains will be examined including intellectual function, processing speed. attention and memory.
arm group label: Cystic Fibrosis
description: Subjects with cystic fibrosis
arm group label: controls
description: matched healthy controls
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis