<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/NCT03296605</url>
  </required_header>
  <id_info>
    <org_study_id>AF/SC-08/02.0</org_study_id>
    <nct_id>NCT03296605</nct_id>
  </id_info>
  <brief_title>Development of Obesity and Bariatric Surgery</brief_title>
  <official_title>Impacts of Bariatric Surgery on Obesity in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</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>
      This study focus on the cause of obesity and impacts of bariatric surgery on it.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">March 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2022</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>Immunity cells</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Ratio of immunity cells in circulating and adipose or liver tissue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight and height</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Body weight and height will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Insulin (mIU/L) concentartions in serum and adipose tissue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Cytokines concentrations in circulating and adipose or liver tissue</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Obesity</arm_group_label>
    <description>Patients with obesity already received bariatric surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>Volunteers with normal body weight and already received abdominal surgery</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, Adipose tissue, Liver tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Obesity patients and controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Body mass index ≥18 kg/m2&#xD;
&#xD;
          2. already received bariatric surgery or abdonimal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. acute stroke or acute myocardial infarction in 6 months&#xD;
&#xD;
          2. autoimmune disease&#xD;
&#xD;
          3. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and&#xD;
             immunosuppressive drugs&#xD;
&#xD;
          4. pregnancy&#xD;
&#xD;
          5. consists with other endocrine diseases&#xD;
&#xD;
          6. acute infection in2 weeks&#xD;
&#xD;
          7. cancer&#xD;
&#xD;
          8. use of antibiotics in 3 months&#xD;
&#xD;
          9. chronic digestive inflammations 9&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation>
    <investigator_full_name>Dalong Zhu</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03296605
org study id: AF/SC-08/02.0
nct id: NCT03296605
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study focus on the cause of obesity and impacts of bariatric surgery on it.
observational model: Case-Control
time perspective: Prospective
measure: Immunity cells
time frame: up to 5 years
description: Ratio of immunity cells in circulating and adipose or liver tissue
measure: Body weight and height
time frame: up to 5 years
description: Body weight and height will be combined to report BMI in kg/m^2
measure: Insulin
time frame: up to 5 years
description: Insulin (mIU/L) concentartions in serum and adipose tissue
measure: Cytokine
time frame: up to 5 years
description: Cytokines concentrations in circulating and adipose or liver tissue
arm group label: Obesity
description: Patients with obesity already received bariatric surgery
arm group label: Healthy control
description: Volunteers with normal body weight and already received abdominal surgery
Blood, Adipose tissue, Liver tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
investigator full name: Dalong Zhu
investigator title: Director
mesh term: Obesity