<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/NCT04430660</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2018-060</org_study_id>
    <nct_id>NCT04430660</nct_id>
  </id_info>
  <brief_title>Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients</brief_title>
  <acronym>GLEAM</acronym>
  <official_title>Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</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>
      A recent pilot study, GLIMPSE (NCT02690168), was recently completed which demonstrated that&#xD;
      the rate of glial acetate metabolism (GAM) is closely associated with susceptibility to&#xD;
      fasting-induced hypoglycemia in healthy adults. Insulin-induced hypoglycemia is a common&#xD;
      complication of diabetes treatment and is a major barrier to the maintenance of healthy&#xD;
      glucose levels in individuals with diabetes. The primary purpose of the study is to test the&#xD;
      proof-of-concept that there is an association between the rate of GAM and susceptibility to&#xD;
      insulin-induced hypoglycemia. In order to observe such a relationship the rate of GAM will be&#xD;
      measured in a patient population known to frequently experience hypoglycemia, i.e.,&#xD;
      individuals with type 1 diabetes mellitus (T1DM).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Actual">May 4, 2022</completion_date>
  <primary_completion_date type="Actual">March 29, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)</measure>
    <time_frame>Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Diabetes</condition>
  <condition>Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will have there glial acetate metabolism assessed via 13C MRS at baseline and then again 14 days later. Participants will wear blinded continuous glucose monitoring devices for ~4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>13C-MRS procedure/Acetate infusion</intervention_name>
    <description>Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous glucose monitoring</intervention_name>
    <description>Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <other_name>CGM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Ages 18-40 years&#xD;
&#xD;
          -  Diagnosed with type 1 diabetes with positive antibodies or dependent on insulin&#xD;
             therapy&#xD;
&#xD;
          -  HbA1c of ≤8.5%&#xD;
&#xD;
          -  Modified Clarke's Hypoglycemia Questionnaire score of 12-24&#xD;
&#xD;
          -  Willing to participate in continuous glucose monitoring (CGM)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to MRI&#xD;
&#xD;
          -  Consume &gt;10 alcoholic drinks/week&#xD;
&#xD;
          -  Current use of CGM&#xD;
&#xD;
          -  Current use of insulin pump&#xD;
&#xD;
          -  Current use of any diabetes medication other than insulin, e.g. SGLT1/2 inhibitors.&#xD;
&#xD;
          -  Current use of steroids, e.g. cortisone, and prednisone.&#xD;
&#xD;
          -  History of chronic smoking or have quit less than 10 years ago&#xD;
&#xD;
          -  History of cancer in the past 5 years (individuals with basal cell or squamous cell&#xD;
             skin cancer would be allowed)&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Significant, cardiac, vascular, pulmonary, gastrointestinal, neurologic, hematologic,&#xD;
             rheumatologic, or psychiatric disease&#xD;
&#xD;
          -  Significant liver disease as defined as more than twice the upper limit of normal for&#xD;
             liver enzymes&#xD;
&#xD;
          -  Significant renal disease as defined as a estimated glomerular filtration rate less&#xD;
             than 30&#xD;
&#xD;
          -  Pregnant, planning to become pregnant, or breastfeeding&#xD;
&#xD;
          -  Have been hospitalized or treated in the past 3 months for severe hypoglycemia&#xD;
&#xD;
          -  Based on the investigative team's clinical judgement, a subject may not be appropriate&#xD;
             for participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808-4124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>David McDougal</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>Hypoglycemia</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/NCT04430660
org study id: PBRC 2018-060
nct id: NCT04430660
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A recent pilot study, GLIMPSE (NCT02690168), was recently completed which demonstrated that
      the rate of glial acetate metabolism (GAM) is closely associated with susceptibility to
      fasting-induced hypoglycemia in healthy adults. Insulin-induced hypoglycemia is a common
      complication of diabetes treatment and is a major barrier to the maintenance of healthy
      glucose levels in individuals with diabetes. The primary purpose of the study is to test the
      proof-of-concept that there is an association between the rate of GAM and susceptibility to
      insulin-induced hypoglycemia. In order to observe such a relationship the rate of GAM will be
      measured in a patient population known to frequently experience hypoglycemia, i.e.,
      individuals with type 1 diabetes mellitus (T1DM).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
time frame: Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart
arm group label: Arm 1
arm group type: Other
description: Participants will have there glial acetate metabolism assessed via 13C MRS at baseline and then again 14 days later. Participants will wear blinded continuous glucose monitoring devices for ~4 weeks.
intervention type: Other
intervention name: 13C-MRS procedure/Acetate infusion
description: Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples.
arm group label: Arm 1
intervention type: Device
intervention name: Continuous glucose monitoring
description: Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.
arm group label: Arm 1
other name: CGM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: David McDougal
investigator title: Assistant Professor
mesh term: Hypoglycemia