<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/NCT01714622</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0550</org_study_id>
    <nct_id>NCT01714622</nct_id>
  </id_info>
  <brief_title>Prospective Cohort Study for Analyzing the Effect of Gastric Cancer Surgery to the Metabolic Syndrome and Insulin Resistance</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastric cancer is still one of the most common malignance in Korea. Because of the popularity&#xD;
      of regular check ups, early detection of gastric cancer has increased, consequently, the&#xD;
      survival of the patients also has increased. In this reason, the interest of outcomes after&#xD;
      gastrectomy for gastric cancer move survival only to quality of life of these patients.&#xD;
&#xD;
      Although the definition of metabolic syndrome is various, but it is normally accepted as a&#xD;
      state that insulin resistance or glucose intolerance combined with hypertension or&#xD;
      hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the&#xD;
      treatment is modification of life style, weight loss and medication. However, in most of the&#xD;
      patients metabolic syndrome is considered not curable disease. Recent studies have shown that&#xD;
      some bariatric surgery offers not only control the overweight but also metabolic syndrome.&#xD;
      The exact mechanism is still unknown but decreased gastric volume and intestinal bypass&#xD;
      itself seemed to play an important role to improve metabolic syndrome over just decreased&#xD;
      weight.&#xD;
&#xD;
      For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied&#xD;
      subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type&#xD;
      is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy,&#xD;
      esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead&#xD;
      decreased gastric volume and/or intestinal bypass, which means this operation could lead&#xD;
      similar effect of bariatric surgery. Already, there have been several retrospective reports&#xD;
      that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no&#xD;
      prospective study about this subject yet in Korea.&#xD;
&#xD;
      The purpose of this study is that evaluating the degree of improvement of metabolic syndrome&#xD;
      after gastrectomy for gastric cancer, and analyze the differences between the type of&#xD;
      operation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Canceled study due to delay of progress procedure and failure to obtain research funds.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the changes of metabolic syndrome</measure>
    <time_frame>baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the changes of insulin resistance after gastrectomy</measure>
    <time_frame>baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Gastric Cancer With Metabolic Syndrome or Metabolic Disease</condition>
  <arm_group>
    <arm_group_label>metabolic syndrome</arm_group_label>
    <description>gastric cancer patients with metabolic syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metabolic disease</arm_group_label>
    <description>gastric cancer patients with metabolic disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal</arm_group_label>
    <description>gastric cancer patients without metabolic syndrome or metabolic disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>subtotal gastrectomy with gastroduodenostomy</intervention_name>
    <arm_group_label>metabolic disease</arm_group_label>
    <arm_group_label>metabolic syndrome</arm_group_label>
    <arm_group_label>normal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>subtotal gastrectomy with Roux-en-Y gastrojejunostomy,</intervention_name>
    <arm_group_label>metabolic disease</arm_group_label>
    <arm_group_label>metabolic syndrome</arm_group_label>
    <arm_group_label>normal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>total gastrectomy with Rou-en-Y esophagojejunostomy</intervention_name>
    <arm_group_label>metabolic disease</arm_group_label>
    <arm_group_label>metabolic syndrome</arm_group_label>
    <arm_group_label>normal</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        in plan to underwent curative gastrectomy for gastric cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. gastric cancer,&#xD;
&#xD;
          2. in plan for gastrectomy for gastric cancer&#xD;
&#xD;
          3. ages between 20 to 85 years old&#xD;
&#xD;
          4. assign in consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. vulnerable subject (pregnant, be devoid of mental capacity, soldiers, or medical&#xD;
             students)&#xD;
&#xD;
          2. had low performance scale due to severe cardiovascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Surgery, Yonsei University Colleage of Medicine,</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ji Yeong An</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sevrance hospital, Department of General surgery</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metabolic syndrome</keyword>
  <keyword>insulin resistance</keyword>
  <keyword>gastric cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Syndrome</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/NCT01714622
org study id: 4-2012-0550
nct id: NCT01714622
lead sponsor: 
has dmc: No
Gastric cancer is still one of the most common malignance in Korea. Because of the popularity
      of regular check ups, early detection of gastric cancer has increased, consequently, the
      survival of the patients also has increased. In this reason, the interest of outcomes after
      gastrectomy for gastric cancer move survival only to quality of life of these patients.

      Although the definition of metabolic syndrome is various, but it is normally accepted as a
      state that insulin resistance or glucose intolerance combined with hypertension or
      hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the
      treatment is modification of life style, weight loss and medication. However, in most of the
      patients metabolic syndrome is considered not curable disease. Recent studies have shown that
      some bariatric surgery offers not only control the overweight but also metabolic syndrome.
      The exact mechanism is still unknown but decreased gastric volume and intestinal bypass
      itself seemed to play an important role to improve metabolic syndrome over just decreased
      weight.

      For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied
      subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type
      is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy,
      esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead
      decreased gastric volume and/or intestinal bypass, which means this operation could lead
      similar effect of bariatric surgery. Already, there have been several retrospective reports
      that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no
      prospective study about this subject yet in Korea.

      The purpose of this study is that evaluating the degree of improvement of metabolic syndrome
      after gastrectomy for gastric cancer, and analyze the differences between the type of
      operation.
observational model: Cohort
time perspective: Prospective
measure: the changes of metabolic syndrome
time frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
measure: the changes of insulin resistance after gastrectomy
time frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
arm group label: metabolic syndrome
description: gastric cancer patients with metabolic syndrome
arm group label: metabolic disease
description: gastric cancer patients with metabolic disease
arm group label: normal
description: gastric cancer patients without metabolic syndrome or metabolic disease
intervention type: Procedure
intervention name: subtotal gastrectomy with gastroduodenostomy
arm group label: metabolic disease
arm group label: metabolic syndrome
arm group label: normal
intervention type: Procedure
intervention name: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,
arm group label: metabolic disease
arm group label: metabolic syndrome
arm group label: normal
intervention type: Procedure
intervention name: total gastrectomy with Rou-en-Y esophagojejunostomy
arm group label: metabolic disease
arm group label: metabolic syndrome
arm group label: normal
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Metabolic Syndrome
mesh term: Insulin Resistance
mesh term: Metabolic Diseases
mesh term: Syndrome