<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/NCT04409171</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBH-GS-HBP6</org_study_id>
    <nct_id>NCT04409171</nct_id>
  </id_info>
  <brief_title>Glucose Metabolism After Partial Pancreatectomy</brief_title>
  <official_title>Alteration of Glucose Metabolism After Partial Pancreatectomy Assessed With Biochemical Markers :A Single Center Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University 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 is a single center observational study to assess alteration of glucose metabolism after&#xD;
      pancreatectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting&#xD;
      blood glucose, insulin, glucagon and HbA1c were performed on patients receiving&#xD;
      pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done&#xD;
      preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the&#xD;
      incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>incidence &amp; risk factors of new-onset DM</measure>
    <time_frame>at 1 year</time_frame>
    <description>incidence &amp; risk factors of new onset DM after pancreatectomy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence &amp; risk factors of worsened DM</measure>
    <time_frame>at 1 year</time_frame>
    <description>incidence &amp; risk factors of worsened DM after pancreatectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>characteristics of new-onset and worsened DM</measure>
    <time_frame>1 year</time_frame>
    <description>changes of glucose metabolism during study period</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">224</enrollment>
  <condition>Pancreatectomy; Hyperglycemia</condition>
  <condition>Diabete Mellitus</condition>
  <arm_group>
    <arm_group_label>PD</arm_group_label>
    <description>pancreaticoduodenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DP</arm_group_label>
    <description>distal pancreatectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>oral glucose tolerance test</intervention_name>
    <arm_group_label>DP</arm_group_label>
    <arm_group_label>PD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients receiving partial pancreatectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  partial pancreatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  total pancreatectomy&#xD;
&#xD;
          -  incomplete testing&#xD;
&#xD;
          -  follow-up loss&#xD;
&#xD;
          -  death within 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Lee BW, Kang HW, Heo JS, Choi SH, Kim SY, Min YK, Chung JH, Lee MK, Lee MS, Kim KW. Insulin secretory defect plays a major role in the development of diabetes in patients with distal pancreatectomy. Metabolism. 2006 Jan;55(1):135-41. doi: 10.1016/j.metabol.2005.08.005.</citation>
    <PMID>16324932</PMID>
  </reference>
  <reference>
    <citation>Hwang HK, Park J, Choi SH, Kang CM, Lee WJ. Predicting new-onset diabetes after minimally invasive subtotal distal pancreatectomy in benign and borderline malignant lesions of the pancreas. Medicine (Baltimore). 2017 Dec;96(51):e9404. doi: 10.1097/MD.0000000000009404.</citation>
    <PMID>29390555</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Yoo-Seok Yoon</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Pancreatectomy</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>pancreaticoduodenectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There are no plans of sharing IPD</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/NCT04409171
org study id: SNUBH-GS-HBP6
nct id: NCT04409171
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a single center observational study to assess alteration of glucose metabolism after
      pancreatectomy.
Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting
      blood glucose, insulin, glucagon and HbA1c were performed on patients receiving
      pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done
      preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the
      incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.
observational model: Cohort
time perspective: Prospective
measure: incidence & risk factors of new-onset DM
time frame: at 1 year
description: incidence & risk factors of new onset DM after pancreatectomy
measure: incidence & risk factors of worsened DM
time frame: at 1 year
description: incidence & risk factors of worsened DM after pancreatectomy
measure: characteristics of new-onset and worsened DM
time frame: 1 year
description: changes of glucose metabolism during study period
arm group label: PD
description: pancreaticoduodenectomy
arm group label: DP
description: distal pancreatectomy
intervention type: Diagnostic Test
intervention name: oral glucose tolerance test
arm group label: DP
arm group label: PD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Lee BW, Kang HW, Heo JS, Choi SH, Kim SY, Min YK, Chung JH, Lee MK, Lee MS, Kim KW. Insulin secretory defect plays a major role in the development of diabetes in patients with distal pancreatectomy. Metabolism. 2006 Jan;55(1):135-41. doi: 10.1016/j.metabol.2005.08.005.
PMID: 16324932
citation: Hwang HK, Park J, Choi SH, Kang CM, Lee WJ. Predicting new-onset diabetes after minimally invasive subtotal distal pancreatectomy in benign and borderline malignant lesions of the pancreas. Medicine (Baltimore). 2017 Dec;96(51):e9404. doi: 10.1097/MD.0000000000009404.
PMID: 29390555
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Yoo-Seok Yoon
investigator title: Associate Professor
mesh term: Hyperglycemia
mesh term: Diabetes Mellitus
sharing ipd: No
ipd description: There are no plans of sharing IPD