<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/NCT03800160</url>
  </required_header>
  <id_info>
    <org_study_id>GC-MBD</org_study_id>
    <nct_id>NCT03800160</nct_id>
  </id_info>
  <brief_title>Greater China Metabolic and Bariatric Surgery Database</brief_title>
  <official_title>Greater China Metabolic and Bariatric Surgery Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Shijitan Hospital, Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanxi Dayi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inner Mongolia People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second People's Hospital of Xinxiang Henan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tangshan Gongren Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Nankai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin First Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Friendship 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>
      Metabolic surgery, as a recognition treatment option for patients with clinical morbid&#xD;
      obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging&#xD;
      studies have highlighted that metabolic surgery can substantially ameliorate obesity-related&#xD;
      metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM),&#xD;
      hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic&#xD;
      ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger&#xD;
      sample size and longer observation time still needed to clarity the efficacy and safety of&#xD;
      metabolic surgery in Chinese patients with obesity and encouraging future research in this&#xD;
      field.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">April 1, 2029</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2028</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>the excess weight loss effect of different metabolic surgeries after 1year</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which &quot;ideal weight&quot; is defined by the weight corresponding to a BMI of 25 kg/m2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the adverse events rate of different metabolic surgeries</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>show the surgical safety by 30 days follow-up according to guideline（such as: bleeding, leak, obstruction, re-operation for complication）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the excess weight loss effect of metabolic surgery with long-time follow-ups</measure>
    <time_frame>3 years</time_frame>
    <description>Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which &quot;ideal weight&quot; is defined by the weight corresponding to a BMI of 25 kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the excess weight loss effect of metabolic surgery with long-time follow-ups</measure>
    <time_frame>5 years</time_frame>
    <description>Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which &quot;ideal weight&quot; is defined by the weight corresponding to a BMI of 25 kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the excess weight loss effect of metabolic surgery with long-time follow-ups</measure>
    <time_frame>10 years</time_frame>
    <description>Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which &quot;ideal weight&quot; is defined by the weight corresponding to a BMI of 25 kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the glycemic control level of metabolic surgery with long-time follow-ups</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>the change of HbA1c, glucose level, C-peptide and insulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the glycemic control level of metabolic surgery with long-time follow-ups</measure>
    <time_frame>3 year after surgery</time_frame>
    <description>the change of HbA1c, glucose level, C-peptide and insulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the glycemic control level of metabolic surgery with long-time follow-ups</measure>
    <time_frame>5 year after surgery</time_frame>
    <description>the change of HbA1c, glucose level, C-peptide and insulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the glycemic control level of metabolic surgery with long-time follow-ups</measure>
    <time_frame>10 year after surgery</time_frame>
    <description>the change of HbA1c, glucose level, C-peptide and insulin levels</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Metabolic Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with morbid obesity who are suitable and willing to accept metabolic surgical&#xD;
        procedure and also agree with the registry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be able to receive metabolic surgery, including but not limit to LSG and LRYGB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  can not be able to understand and willing to participate in this registry with&#xD;
             signature&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>May 4, 2020</last_update_submitted>
  <last_update_submitted_qc>May 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Zhongtao Zhang</investigator_full_name>
    <investigator_title>Director of general surgery, principal investigator</investigator_title>
  </responsible_party>
  <keyword>metabolic surgery</keyword>
  <keyword>metabolic disease</keyword>
  <keyword>multicenter</keyword>
  <!-- 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/NCT03800160
org study id: GC-MBD
nct id: NCT03800160
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Metabolic surgery, as a recognition treatment option for patients with clinical morbid
      obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging
      studies have highlighted that metabolic surgery can substantially ameliorate obesity-related
      metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM),
      hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic
      ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger
      sample size and longer observation time still needed to clarity the efficacy and safety of
      metabolic surgery in Chinese patients with obesity and encouraging future research in this
      field.
observational model: Case-Only
time perspective: Prospective
measure: the excess weight loss effect of different metabolic surgeries after 1year
time frame: 1 year after surgery
description: Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
measure: the adverse events rate of different metabolic surgeries
time frame: 30 days after surgery
description: show the surgical safety by 30 days follow-up according to guideline（such as: bleeding, leak, obstruction, re-operation for complication）
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
time frame: 3 years
description: Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
time frame: 5 years
description: Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
time frame: 10 years
description: Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
measure: the glycemic control level of metabolic surgery with long-time follow-ups
time frame: 1 year after surgery
description: the change of HbA1c, glucose level, C-peptide and insulin levels
measure: the glycemic control level of metabolic surgery with long-time follow-ups
time frame: 3 year after surgery
description: the change of HbA1c, glucose level, C-peptide and insulin levels
measure: the glycemic control level of metabolic surgery with long-time follow-ups
time frame: 5 year after surgery
description: the change of HbA1c, glucose level, C-peptide and insulin levels
measure: the glycemic control level of metabolic surgery with long-time follow-ups
time frame: 10 year after surgery
description: the change of HbA1c, glucose level, C-peptide and insulin levels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Zhongtao Zhang
investigator title: Director of general surgery, principal investigator