<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/NCT03246828</url>
  </required_header>
  <id_info>
    <org_study_id>12538</org_study_id>
    <nct_id>NCT03246828</nct_id>
  </id_info>
  <brief_title>Glucagon in MODY (Maturity Onset Diabetes of the Young)</brief_title>
  <official_title>Investigating Glucagon Secretion in HNF1-alpha and HNF4-alpha MODY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</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 aim of this study is to determine whether fasting and post-prandial glucagon secretion is&#xD;
      suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an&#xD;
      oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for&#xD;
      3 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2017</start_date>
  <completion_date type="Actual">August 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in plasma glucagon from baseline (0min)</measure>
    <time_frame>0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.</time_frame>
    <description>Change in the concentration of plasma glucagon from baseline during an oral glucose tolerance test (OGTT), while on gliclazide and after a washout period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma c-peptide from baseline (0min)</measure>
    <time_frame>0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.</time_frame>
    <description>To determine whether changes in post-prandial glucagon levels correlate with changes in c-peptide levels in HNF1-/4-alpha MODY patients on and off gliclazide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)</measure>
    <time_frame>0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.</time_frame>
    <description>To determine whether changes in post-prandial glucagon levels correlate with changes in NEFA levels in HNF1-/4-alpha MODY patients on and off gliclazide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous glucose monitor recordings</measure>
    <time_frame>12 days</time_frame>
    <description>To assess the blood glucose variability on and off gliclazide treatment (only for participants who opt to take part in this optional component).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>MODY1</condition>
  <condition>MODY3</condition>
  <arm_group>
    <arm_group_label>Omission of gliclazide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Omission of gliclazide</intervention_name>
    <description>Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.</description>
    <arm_group_label>Omission of gliclazide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of HNF1-alpha or HNF4-alpha MODY.&#xD;
&#xD;
          -  Currently on gliclazide treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently taking any anti-diabetic medication other than gliclazide and metformin&#xD;
&#xD;
          -  Oral steroid treatment 30 days prior to the start or at any time during the study&#xD;
             period.&#xD;
&#xD;
          -  Known malignancy or any other condition or circumstance which, in the opinion of the&#xD;
             investigator, would affect the patient's ability to participate in the protocol.&#xD;
&#xD;
          -  Felt to be unsuitable to participate in the study in the opinion of the Chief&#xD;
             Investigator.&#xD;
&#xD;
          -  Currently participating in a clinical trial involving an anti-diabetic medication&#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>Ioannis Spiliotis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Unit, OCDEM, Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gliclazide</keyword>
  <keyword>glucagon</keyword>
  <keyword>diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gliclazide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The anonymised data (i.e. with studyID only) generated from this study will be deposited in the Oxford Research Archive (http://ora.ox.ac.uk/). This will provide a link between the results presented in publications and the underlying data. At the end of the retention period (currently 5 years), the data will be deleted from the archive. The anonymised data may still be used in future research.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>July 3, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03246828
org study id: 12538
nct id: NCT03246828
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine whether fasting and post-prandial glucagon secretion is
      suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an
      oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for
      3 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in plasma glucagon from baseline (0min)
time frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
description: Change in the concentration of plasma glucagon from baseline during an oral glucose tolerance test (OGTT), while on gliclazide and after a washout period.
measure: Change in plasma c-peptide from baseline (0min)
time frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
description: To determine whether changes in post-prandial glucagon levels correlate with changes in c-peptide levels in HNF1-/4-alpha MODY patients on and off gliclazide.
measure: Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)
time frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
description: To determine whether changes in post-prandial glucagon levels correlate with changes in NEFA levels in HNF1-/4-alpha MODY patients on and off gliclazide.
measure: Continuous glucose monitor recordings
time frame: 12 days
description: To assess the blood glucose variability on and off gliclazide treatment (only for participants who opt to take part in this optional component).
arm group label: Omission of gliclazide
arm group type: Experimental
intervention type: Other
intervention name: Omission of gliclazide
description: Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.
arm group label: Omission of gliclazide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ioannis Spiliotis, MD
role: Principal Investigator
affiliation: University of Oxford
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Gliclazide
sharing ipd: Yes
ipd description: The anonymised data (i.e. with studyID only) generated from this study will be deposited in the Oxford Research Archive (http://ora.ox.ac.uk/). This will provide a link between the results presented in publications and the underlying data. At the end of the retention period (currently 5 years), the data will be deleted from the archive. The anonymised data may still be used in future research.
submitted: July 3, 2023