<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/NCT02186080</url>
  </required_header>
  <id_info>
    <org_study_id>H-1401-089-550</org_study_id>
    <nct_id>NCT02186080</nct_id>
  </id_info>
  <brief_title>Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia</brief_title>
  <official_title>Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes.&#xD;
      The investigators will measure systemic endotoxin level and lipid level after ingestion of&#xD;
      high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic&#xD;
      endotoxemia and lipemia induced by high fat diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study subjects will be allocated to either gemigliptin or placebo. After 4 weeks of treatment&#xD;
      and 2 weeks of wash out period, all subjects will be switched to the opposite arm.&#xD;
&#xD;
      The subjects will be tested oral fat tolerance test and adipose tissue needle biopsy(only for&#xD;
      the subjects who agreed to participate donate adipose tissue) at 3 time points: the start of&#xD;
      1st treatment, end of 1st treatment and end of 2nd treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between baseline and peak serum LPS</measure>
    <time_frame>serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet</time_frame>
    <description>The increment of serum LPS after ingestion of high fat diet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting serum LPS level</measure>
    <time_frame>After 10 hrs of fasting</time_frame>
    <description>Compare fasting LPS level between treatment group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental AUC of serum LPS during oral fat tolerance test</measure>
    <time_frame>serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet</time_frame>
    <description>Calculated incremental AUC of serum LPS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between baseline and peak serum triglyceride level</measure>
    <time_frame>serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet</time_frame>
    <description>The increment of serum TG after ingestion of high fat diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental AUC of serum triglyceride level during oral fat tolerance test</measure>
    <time_frame>serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet</time_frame>
    <description>Calculated incremental AUC of serum TG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between baseline and peak serum apolipoprotein-B48</measure>
    <time_frame>serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet</time_frame>
    <description>The increment of serum apolipoprotein-B48 after ingestion of high fat diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test</measure>
    <time_frame>serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet</time_frame>
    <description>Calculated incremental AUC of serum apolipoprotein-B48</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)</measure>
    <time_frame>After 10 hr of fasting</time_frame>
    <description>Compare serum level of inflammatory markers between treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mRNA expression level of inflammatory markers in the adipose tissue</measure>
    <time_frame>After high fat diet ingestion</time_frame>
    <description>Compare mRNA expression level of inflammatory markers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Gemigliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemigliptin 50mg qd added to subjects current diabetes treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (identical in appearance to gemigliptin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemigliptin</intervention_name>
    <arm_group_label>Gemigliptin</arm_group_label>
    <other_name>Zemiglo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 20 to 75&#xD;
&#xD;
          -  At least 6 months from the diagnosis of type 2 diabetes&#xD;
&#xD;
          -  Current diabetes treatment: life style modification and/or metformin and/or&#xD;
             sulfornylurea&#xD;
&#xD;
          -  No change of the diabetes treatment (drug number and dossage) in recent 3 months&#xD;
&#xD;
          -  HbA1c 6.5% to 10%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent cardiovascular event in 6 months&#xD;
&#xD;
          -  Concurrent use of statin or fibrate or ezetimibe&#xD;
&#xD;
          -  Renal failure, chronic liver disease&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Use of other DPP-4 inhibitor or GLP-1 analogue in recent 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young Min Cho, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 20, 2016</last_update_submitted>
  <last_update_submitted_qc>April 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes mellitus</keyword>
  <keyword>metabolic endotoxemia</keyword>
  <keyword>gemigliptin</keyword>
  <keyword>DPP-4 inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endotoxemia</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02186080
org study id: H-1401-089-550
nct id: NCT02186080
lead sponsor: 
collaborator: 
has dmc: Yes
This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes.
      The investigators will measure systemic endotoxin level and lipid level after ingestion of
      high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic
      endotoxemia and lipemia induced by high fat diet.
Study subjects will be allocated to either gemigliptin or placebo. After 4 weeks of treatment
      and 2 weeks of wash out period, all subjects will be switched to the opposite arm.

      The subjects will be tested oral fat tolerance test and adipose tissue needle biopsy(only for
      the subjects who agreed to participate donate adipose tissue) at 3 time points: the start of
      1st treatment, end of 1st treatment and end of 2nd treatment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference between baseline and peak serum LPS
time frame: serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
description: The increment of serum LPS after ingestion of high fat diet
measure: Fasting serum LPS level
time frame: After 10 hrs of fasting
description: Compare fasting LPS level between treatment group
measure: Incremental AUC of serum LPS during oral fat tolerance test
time frame: serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
description: Calculated incremental AUC of serum LPS
measure: Difference between baseline and peak serum triglyceride level
time frame: serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
description: The increment of serum TG after ingestion of high fat diet
measure: Incremental AUC of serum triglyceride level during oral fat tolerance test
time frame: serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
description: Calculated incremental AUC of serum TG
measure: Difference between baseline and peak serum apolipoprotein-B48
time frame: serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
description: The increment of serum apolipoprotein-B48 after ingestion of high fat diet
measure: Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test
time frame: serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
description: Calculated incremental AUC of serum apolipoprotein-B48
measure: Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)
time frame: After 10 hr of fasting
description: Compare serum level of inflammatory markers between treatment groups
measure: mRNA expression level of inflammatory markers in the adipose tissue
time frame: After high fat diet ingestion
description: Compare mRNA expression level of inflammatory markers
arm group label: Gemigliptin
arm group type: Experimental
description: Gemigliptin 50mg qd added to subjects current diabetes treatment
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (identical in appearance to gemigliptin)
intervention type: Drug
intervention name: Gemigliptin
arm group label: Gemigliptin
other name: Zemiglo
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Young Min Cho, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Endotoxemia
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No