<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/NCT02199470</url>
  </required_header>
  <id_info>
    <org_study_id>MUGEAH-1</org_study_id>
    <nct_id>NCT02199470</nct_id>
  </id_info>
  <brief_title>β-cell Function in Type 1 Diabetes May Not Be As Low As Presumed</brief_title>
  <official_title>β-cell Function in Type Diabetes May Not Be As Low As Presumed</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gonca Incemehmet Tamer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medeniyet University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve&#xD;
      glycemic control and decrease complications and rates of mortality. However, it can be&#xD;
      succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of&#xD;
      β-cell function by determining fasting levels of C-peptide and those after meal stimulus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and aims: Enhancing endogenous insulin production in type 1 diabetic patients&#xD;
      (T1DP) can improve glycemic control and decrease complications and rates of mortality.&#xD;
      However, it can be succesfull even if sufficient β-cell function is present. We aimed to&#xD;
      evaluate the extent of β-cell function by determining fasting levels of C-peptide and those&#xD;
      after meal stimulus.&#xD;
&#xD;
      Materials and Methods: One hundred and thiryfive T1DP were planned to enrolı to the study.&#xD;
      Ethics comittee of our hospital approved the study protocol, which was in accordance with the&#xD;
      Helsinki Declaration. Fasting C-peptide levels of all participants and stimulated (at 90 th&#xD;
      minute post mixed meal) C-peptide levels of 54 will be measured by using an&#xD;
      electrochemiluminescence assay. Two categorizations will be done using fasting (the first&#xD;
      categorization ) and at 90th minute post mixed meal test (the second categorization) of&#xD;
      C-peptide levels. For the first categorization; the groups will be classified as follows:&#xD;
      patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and&#xD;
      with sustained ≥0.8 ng/mL(group 3) C-peptide levels. For the second categorization, groups&#xD;
      will be as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8&#xD;
      ng/ml (group 2); and with sustained ≥0.8 ng/mL (group 3) C-peptide levels which increased at&#xD;
      the 90th minute after the meal ≥150% of fasting C-peptide level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</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>We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.</measure>
    <time_frame>1 day (the duration of mixed test is 90 minutes)</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">135</enrollment>
  <condition>TYPE 1 DIABETES</condition>
  <arm_group>
    <arm_group_label>C-peptide minimal detectable</arm_group_label>
    <description>C-peptide level between 0,01-0,08 ng/mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C-peptide sustained</arm_group_label>
    <description>C-peptide level between higher or equal to 0,08 ng/mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C-peptide not detectable</arm_group_label>
    <description>C- peptide level equal to or lower than 0,01 ng/mL</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum c-peptide levels&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with type 1 diabetes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetic patients who have accepted to have mixed meal tolarance test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with type 2 diabetes,&#xD;
&#xD;
          -  patients with MODY&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gonca Incemehmet Tamer, I</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul Medeniyet University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medeniyet University Goztepe Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34730</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://creativecommons.org/licenses/by-nc-nd/3.0/</url>
    <description>Joslin Medalist Study</description>
  </link>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>September 2, 2016</last_update_submitted>
  <last_update_submitted_qc>September 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
    <investigator_full_name>Gonca Incemehmet Tamer</investigator_full_name>
    <investigator_title>Istanbul Medeniyet University, Goztepe Research and Training Hospital</investigator_title>
  </responsible_party>
  <keyword>β-CELLS,</keyword>
  <keyword>MIXED MEAL TEST,</keyword>
  <keyword>C-PEPTİDE</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 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/NCT02199470
org study id: MUGEAH-1
nct id: NCT02199470
lead sponsor: 
has dmc: No
Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve
      glycemic control and decrease complications and rates of mortality. However, it can be
      succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of
      β-cell function by determining fasting levels of C-peptide and those after meal stimulus.
Background and aims: Enhancing endogenous insulin production in type 1 diabetic patients
      (T1DP) can improve glycemic control and decrease complications and rates of mortality.
      However, it can be succesfull even if sufficient β-cell function is present. We aimed to
      evaluate the extent of β-cell function by determining fasting levels of C-peptide and those
      after meal stimulus.

      Materials and Methods: One hundred and thiryfive T1DP were planned to enrolı to the study.
      Ethics comittee of our hospital approved the study protocol, which was in accordance with the
      Helsinki Declaration. Fasting C-peptide levels of all participants and stimulated (at 90 th
      minute post mixed meal) C-peptide levels of 54 will be measured by using an
      electrochemiluminescence assay. Two categorizations will be done using fasting (the first
      categorization ) and at 90th minute post mixed meal test (the second categorization) of
      C-peptide levels. For the first categorization; the groups will be classified as follows:
      patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and
      with sustained ≥0.8 ng/mL(group 3) C-peptide levels. For the second categorization, groups
      will be as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8
      ng/ml (group 2); and with sustained ≥0.8 ng/mL (group 3) C-peptide levels which increased at
      the 90th minute after the meal ≥150% of fasting C-peptide level.
observational model: Case-Control
time perspective: Prospective
measure: We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.
time frame: 1 day (the duration of mixed test is 90 minutes)
arm group label: C-peptide minimal detectable
description: C-peptide level between 0,01-0,08 ng/mL
arm group label: C-peptide sustained
description: C-peptide level between higher or equal to 0,08 ng/mL
arm group label: C-peptide not detectable
description: C- peptide level equal to or lower than 0,01 ng/mL
Serum c-peptide levels
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Gonca Incemehmet Tamer, I
role: Principal Investigator
affiliation: Istanbul Medeniyet University
facility: 
country: Turkey
url: http://creativecommons.org/licenses/by-nc-nd/3.0/
description: Joslin Medalist Study
responsible party type: Sponsor-Investigator
investigator affiliation: Istanbul Medeniyet University
investigator full name: Gonca Incemehmet Tamer
investigator title: Istanbul Medeniyet University, Goztepe Research and Training Hospital
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1