<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/NCT01735253</url>
  </required_header>
  <id_info>
    <org_study_id>inha 09-58</org_study_id>
    <nct_id>NCT01735253</nct_id>
  </id_info>
  <brief_title>Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients</brief_title>
  <acronym>T2DM</acronym>
  <official_title>Metabolic Surgery for Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inha University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inha University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical treatment for type 2 diabetes has been taken note especially in less obese or non&#xD;
      obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater&#xD;
      than that of the obese.&#xD;
&#xD;
      We are trying to do a prospective observational study for the evaluation of the effect of&#xD;
      duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.&#xD;
&#xD;
      The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral&#xD;
      obesity, insulin use less than 10 years and the patients understanding the hypothesis of this&#xD;
      study, risks, expecting effects and agreeing this study.&#xD;
&#xD;
      We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some&#xD;
      anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.&#xD;
&#xD;
      We will compare the clinical factors at each time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2009</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin A1C</measure>
    <time_frame>preoperatively, at 3month, at 12 month</time_frame>
    <description>change of the level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oral glucose tolerance test</measure>
    <time_frame>preopertively, postoperatively, at 3 month, at 12 month</time_frame>
    <description>changes of the level at each time</description>
  </secondary_outcome>
  <other_outcome>
    <measure>insulin level</measure>
    <time_frame>preoperatively, postoperatively, at 3 month, at 12 month</time_frame>
    <description>change the levels</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Non Insulin Dependent Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>gastric bypass, duodenojejunal bypass</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic roux en Y gastric bypass / open duodenojejunal bypass</intervention_name>
    <description>routine GBP with 80cm roux and biliopancreatic limb</description>
    <arm_group_label>gastric bypass, duodenojejunal bypass</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 2 diabetes&#xD;
&#xD;
          -  HbA1C &gt; 7.0%&#xD;
&#xD;
          -  BMI 23 - 34 or BMI 21-22 with viceral obesity&#xD;
&#xD;
          -  insulin use less than 10 years&#xD;
&#xD;
          -  uncerstanding the risks, hypothesis, expecting effects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  type 1 diabetes&#xD;
&#xD;
          -  C-peptide &lt; 1.0ng/ml&#xD;
&#xD;
          -  BMI &lt; 21&#xD;
&#xD;
          -  severe cardiovascular diseases or their history&#xD;
&#xD;
          -  malignancy or history&#xD;
&#xD;
          -  alcoholics, pituitary failrue&#xD;
&#xD;
          -  history of severe ketosis, diabetic coma or precoma&#xD;
&#xD;
          -  abnormal liver enzyme, over 3 fold of normal level&#xD;
&#xD;
          -  liver cirrhosis or hepatitis&#xD;
&#xD;
          -  serum creatinine &gt; 2.0mg/dL&#xD;
&#xD;
          -  glucocorticoids user&#xD;
&#xD;
          -  diabetes due to other endocrine diseases&#xD;
&#xD;
          -  pancreatic disease&#xD;
&#xD;
          -  anti-GAD Ab (+)&#xD;
&#xD;
          -  the incongruity for surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yoonseok Heo</name>
      <address>
        <city>Incheon</city>
        <zip>400-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 27, 2012</last_update_submitted>
  <last_update_submitted_qc>November 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inha University Hospital</investigator_affiliation>
    <investigator_full_name>Inha University Hospital</investigator_full_name>
    <investigator_title>IRB Inha University Hospital</investigator_title>
  </responsible_party>
  <keyword>metabolic surgery</keyword>
  <keyword>gastric bypass</keyword>
  <keyword>duodenojejunal bypass</keyword>
  <keyword>type 2 DM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01735253
org study id: inha 09-58
nct id: NCT01735253
lead sponsor: 
has dmc: Yes
Surgical treatment for type 2 diabetes has been taken note especially in less obese or non
      obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater
      than that of the obese.

      We are trying to do a prospective observational study for the evaluation of the effect of
      duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.

      The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral
      obesity, insulin use less than 10 years and the patients understanding the hypothesis of this
      study, risks, expecting effects and agreeing this study.

      We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some
      anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.

      We will compare the clinical factors at each time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hemoglobin A1C
time frame: preoperatively, at 3month, at 12 month
description: change of the level
measure: oral glucose tolerance test
time frame: preopertively, postoperatively, at 3 month, at 12 month
description: changes of the level at each time
measure: insulin level
time frame: preoperatively, postoperatively, at 3 month, at 12 month
description: change the levels
arm group label: gastric bypass, duodenojejunal bypass
arm group type: Experimental
intervention type: Procedure
intervention name: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
description: routine GBP with 80cm roux and biliopancreatic limb
arm group label: gastric bypass, duodenojejunal bypass
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Inha University Hospital
investigator full name: Inha University Hospital
investigator title: IRB Inha University Hospital
mesh term: Diabetes Mellitus, Type 2