<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/NCT04495881</url>
  </required_header>
  <id_info>
    <org_study_id>2020-DM-Sitagliptin</org_study_id>
    <nct_id>NCT04495881</nct_id>
  </id_info>
  <brief_title>Sitagliptin for the Treatment of Type 2 Diabetes</brief_title>
  <official_title>Effectiveness of Sitagliptin for the Treatment of Newly Diagnosed Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chao Yang Hospital</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>
      Patients newly diagnosed with T2D will be recruited and will receive sitagliptin treatment&#xD;
      for 3 months. The gut microbiome of the participants before and after the treatment and the&#xD;
      effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The dipeptidyl peptidase-4 inhibitor sitagliptin is a classic anti-diabetic drug(1) and is&#xD;
      widely applied to both scientific research and clinical trial(2-6). This clinical trial aims&#xD;
      to study the effectiveness of sitagliptin treatment in T2D patients and related change of gut&#xD;
      microbiome. 50 Patients newly diagnosed with T2D will be recruited. With patient's informed&#xD;
      consent, patient-related vital signs (such as age, height, weight, body mass index),&#xD;
      laboratory indicators (including glycated hemoglobin, glycated albumin, low-density&#xD;
      lipoprotein, total cholesterol, triglycerides), fasting blood glucose, insulin levels and&#xD;
      Insulin resistance index (HOMA-IR)(7) will be recorded and analyzed. The feces of the&#xD;
      patients will be collected to analyze the gut microbiome. All of the patients will receive&#xD;
      the sitagliptin treatment for 3 months. The gut microbiome of the patients and the&#xD;
      effectiveness of sitagliptin treatment on diabetes will be evaluated at indicated times&#xD;
      during follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
  <phase>Phase 4</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>HbA1c change</measure>
    <time_frame>Changes in HbA1c from baseline at 1 month and 3 months during follow-up</time_frame>
    <description>Changes in HbA1c from baseline at 1 month and 3 months during follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fasting blood glucose change</measure>
    <time_frame>Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up</time_frame>
    <description>Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR change</measure>
    <time_frame>Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up</time_frame>
    <description>Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycated Albumin（GSA）change</measure>
    <time_frame>Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up</time_frame>
    <description>Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>sitagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sitagliptin 100mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin 100mg</intervention_name>
    <description>Sitagliptin 100mg Qd</description>
    <arm_group_label>sitagliptin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18-65 years old newly diagnosed with type 2 diabetes&#xD;
&#xD;
          -  HbA1c ≥ 7%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The positive of diabetes antibodies&#xD;
&#xD;
          -  Anti-diabetic drugs therapy before participation&#xD;
&#xD;
          -  Pancreatitis&#xD;
&#xD;
          -  Coronary artery disease&#xD;
&#xD;
          -  Liver function impairment&#xD;
&#xD;
          -  Renal function impairment&#xD;
&#xD;
          -  History of intestinal surgery&#xD;
&#xD;
          -  Chronic hypoxic diseases (emphysema and cor pulmonale)&#xD;
&#xD;
          -  Infectious disease&#xD;
&#xD;
          -  Hematological disease&#xD;
&#xD;
          -  Systemic inflammatory disease&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Ingesting agents known to influence glucose or lipid metabolism;&#xD;
&#xD;
          -  Any antibiotics or probiotics in the past three months prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guang Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jia Liu, MD</last_name>
    <phone>010-85231710</phone>
    <email>liujia0116@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yan Duan, MD</last_name>
    <phone>010-85231711</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Chao-Yang Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jia liu, MD</last_name>
      <phone>861085231710</phone>
      <email>liujia0116@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Guang Wang</investigator_full_name>
    <investigator_title>Professor and Director, Department of Endocrinology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <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>Sitagliptin Phosphate</mesh_term>
  </intervention_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/NCT04495881
org study id: 2020-DM-Sitagliptin
nct id: NCT04495881
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients newly diagnosed with T2D will be recruited and will receive sitagliptin treatment
      for 3 months. The gut microbiome of the participants before and after the treatment and the
      effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.
The dipeptidyl peptidase-4 inhibitor sitagliptin is a classic anti-diabetic drug(1) and is
      widely applied to both scientific research and clinical trial(2-6). This clinical trial aims
      to study the effectiveness of sitagliptin treatment in T2D patients and related change of gut
      microbiome. 50 Patients newly diagnosed with T2D will be recruited. With patient's informed
      consent, patient-related vital signs (such as age, height, weight, body mass index),
      laboratory indicators (including glycated hemoglobin, glycated albumin, low-density
      lipoprotein, total cholesterol, triglycerides), fasting blood glucose, insulin levels and
      Insulin resistance index (HOMA-IR)(7) will be recorded and analyzed. The feces of the
      patients will be collected to analyze the gut microbiome. All of the patients will receive
      the sitagliptin treatment for 3 months. The gut microbiome of the patients and the
      effectiveness of sitagliptin treatment on diabetes will be evaluated at indicated times
      during follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: HbA1c change
time frame: Changes in HbA1c from baseline at 1 month and 3 months during follow-up
description: Changes in HbA1c from baseline at 1 month and 3 months during follow-up
measure: fasting blood glucose change
time frame: Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up
description: Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up
measure: HOMA-IR change
time frame: Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up
description: Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up
measure: Glycated Albumin（GSA）change
time frame: Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up
description: Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up
arm group label: sitagliptin
arm group type: Experimental
description: sitagliptin 100mg
intervention type: Drug
intervention name: Sitagliptin 100mg
description: Sitagliptin 100mg Qd
arm group label: sitagliptin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Guang Wang, MD
role: Principal Investigator
affiliation: Beijing Chao Yang Hospital
last name: Jia Liu, MD
phone: 010-85231710
email: liujia0116@126.com
last name: Yan Duan, MD
phone: 010-85231711
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Guang Wang
investigator title: Professor and Director, Department of Endocrinology
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Sitagliptin Phosphate