<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/NCT04426422</url>
  </required_header>
  <id_info>
    <org_study_id>GUTT2DM</org_study_id>
    <nct_id>NCT04426422</nct_id>
  </id_info>
  <brief_title>Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes</brief_title>
  <official_title>Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenzhen People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study was aimed to investigate the effect of metformin on the gut microbiota and&#xD;
      glycemic control in newly diagnosed type 2 diabetes patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was aimed to investigate the effect of metformin on the gut microbiota and&#xD;
      glycemic control in newly diagnosed type 2 diabetes patients. All the recurited patients were&#xD;
      treated with metformin 1500-2000mg daily for 3 months. Stool specimens and blood samples were&#xD;
      collected at the beginning and 3 months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>
    <intervention_model_description>newly diagnosed type 2 diabetes was treated with metfomin for 3 months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gut micribiota</measure>
    <time_frame>3 months</time_frame>
    <description>the changes of gut micribiota</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>glycemic control</measure>
    <time_frame>3 months</time_frame>
    <description>HbA1c</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>metformin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>all the patients were treated with metformin 1500-2000mg daily for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin Hydrochloride</intervention_name>
    <description>treated with metformin 1500-2000mg daily</description>
    <arm_group_label>metformin group</arm_group_label>
    <other_name>intervention group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        newly diagnosis type 2 diabetes ,HbA1c &gt;7 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        history of cardiovascular disease, hypertension, severe renal dysfunction defined as&#xD;
        glomerular filtration rate &lt; 45 mL/min/1.73 m2; severe illness or diabetic ketoacidosis&#xD;
        within 30 days, inability to tolerate ≥500 mg metformin twice per day and pregnancy.&#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>fengyi Yuan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shenzhen People' hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shenzhen People' S Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Metformin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no decided yet.</ipd_description>
  </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/NCT04426422
org study id: GUTT2DM
nct id: NCT04426422
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was aimed to investigate the effect of metformin on the gut microbiota and
      glycemic control in newly diagnosed type 2 diabetes patients.
This study was aimed to investigate the effect of metformin on the gut microbiota and
      glycemic control in newly diagnosed type 2 diabetes patients. All the recurited patients were
      treated with metformin 1500-2000mg daily for 3 months. Stool specimens and blood samples were
      collected at the beginning and 3 months later.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: newly diagnosed type 2 diabetes was treated with metfomin for 3 months.
primary purpose: Treatment
masking: None (Open Label)
measure: gut micribiota
time frame: 3 months
description: the changes of gut micribiota
measure: glycemic control
time frame: 3 months
description: HbA1c
arm group label: metformin group
arm group type: Experimental
description: all the patients were treated with metformin 1500-2000mg daily for 3 months.
intervention type: Drug
intervention name: Metformin Hydrochloride
description: treated with metformin 1500-2000mg daily
arm group label: metformin group
other name: intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: fengyi Yuan
role: Principal Investigator
affiliation: Shenzhen People' hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
sharing ipd: No
ipd description: no decided yet.