<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/NCT03030209</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-GS03</org_study_id>
    <nct_id>NCT03030209</nct_id>
  </id_info>
  <brief_title>Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy</brief_title>
  <official_title>Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glucose homeostasis changes after distal pancreatectomy are not well understood. This study&#xD;
      aim to identify the incidence of and risk factors for, a change in glucose homeostasis in&#xD;
      patients who underwent distal pancreatic resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The development of sophisticated surgical procedures, improved postoperative care, and the&#xD;
      capacity for early diagnosis of disease, have prolonged life expectancy after pancreatic&#xD;
      resection. For these patients, the endocrine function of the pancreas is a critical factor&#xD;
      that influences quality of life. In this study, the investigators recruit patients who&#xD;
      underwent distal pancreatectomy in Peking Union Medical College Hospital within the last 10&#xD;
      years. Demographic characteristics, operative parameters and short-term postoperative&#xD;
      outcomes were collected in a prospective database maintained by the Pancreatic Surgical&#xD;
      Centre, Peking Union Medical College Hospital. These patients are followed up regularly by&#xD;
      outpatient visiting or telephone for long-term outcomes. The primary outcome of this study is&#xD;
      new-onset diabetes mellitus; second outcomes include impaired fasting glucose, impaired&#xD;
      glucose tolerance, exocrine insufficiency and disease recurrence. This study aim to determine&#xD;
      the cumulative rates of endocrine insufficiency, and identify risk factors for DM development&#xD;
      in a large cohort of patients undergoing distal pancreatectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2004</start_date>
  <completion_date type="Actual">February 13, 2016</completion_date>
  <primary_completion_date type="Actual">February 13, 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>Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association</measure>
    <time_frame>Through study completion, an average of 3 year</time_frame>
    <description>The criteria for the diagnosis of diabetes developed by American Diabetes Association (1) FPG (fasting plasma glucose) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.* OR (2) 2-h PG (plasma glucose) ≥ 200 mg/dL (11.1mmol/L) during an OGTT (oral glucose tolerance test). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.* OR (3) A1C ≥ 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.* (lower-upper limit: 4.5%-6.3% in PUMCH) OR (4) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).&#xD;
*In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with new-onset prediabetes as defined by American Diabetes Association</measure>
    <time_frame>Through study completion, an average of 3 year</time_frame>
    <description>The categories of prediabetes (increased risk for diabetes)&#xD;
(1) Impaired fasting glucose (IFG): FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L). (3.6 - 6.1 mmol/L in PUMCH) OR (2) Impaired glucose tolerance (IGT): 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.&#xD;
OR (3) A1C 5.7-6.4% (39-46 mmol/mol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with new-onset exocrine insufficiency</measure>
    <time_frame>Through study completion, an average of 3 year</time_frame>
    <description>Exocrine insufficiency is defined as patients requiring oral pancreatic enzyme replacement because of severe diarrhea.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">485</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Distal Pancreatectomy</arm_group_label>
    <description>Patients undergoing distal pancreatectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Distal pancreatectomy</intervention_name>
    <description>Distal pancreatectomy with or without splenectomy using minimal invasive or open approach</description>
    <arm_group_label>Distal Pancreatectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing distal pancreatectomy at our single tertiary referral hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing distal pancreatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing pancreaticoduodenectomy, middle pancreatectomy and enucleation&#xD;
&#xD;
          -  Patients with preoperative DM&#xD;
&#xD;
          -  Patients with functioning insulinoma and multiple endocrine neoplasia type 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Menghua Dai, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Kwon JH, Kim SC, Shim IK, Song KB, Lee JH, Hwang DW, Park KM, Lee YJ. Factors Affecting the Development of Diabetes Mellitus After Pancreatic Resection. Pancreas. 2015 Nov;44(8):1296-303. doi: 10.1097/MPA.0000000000000404.</citation>
    <PMID>26390413</PMID>
  </reference>
  <reference>
    <citation>Shirakawa S, Matsumoto I, Toyama H, Shinzeki M, Ajiki T, Fukumoto T, Ku Y. Pancreatic volumetric assessment as a predictor of new-onset diabetes following distal pancreatectomy. J Gastrointest Surg. 2012 Dec;16(12):2212-9. doi: 10.1007/s11605-012-2039-7. Epub 2012 Sep 28.</citation>
    <PMID>23054900</PMID>
  </reference>
  <reference>
    <citation>King J, Kazanjian K, Matsumoto J, Reber HA, Yeh MW, Hines OJ, Eibl G. Distal pancreatectomy: incidence of postoperative diabetes. J Gastrointest Surg. 2008 Sep;12(9):1548-53. doi: 10.1007/s11605-008-0560-5. Epub 2008 Jun 10.</citation>
    <PMID>18543045</PMID>
  </reference>
  <reference>
    <citation>You DD, Choi SH, Choi DW, Heo JS, Ho CY, Kim WS. Long-term effects of pancreaticoduodenectomy on glucose metabolism. ANZ J Surg. 2012 Jun;82(6):447-51. doi: 10.1111/j.1445-2197.2012.06080.x. Epub 2012 May 9.</citation>
    <PMID>22571457</PMID>
  </reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 17, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreatectomy</keyword>
  <keyword>diabetes mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03030209
org study id: PUMCH-GS03
nct id: NCT03030209
lead sponsor: 
has dmc: Yes
Glucose homeostasis changes after distal pancreatectomy are not well understood. This study
      aim to identify the incidence of and risk factors for, a change in glucose homeostasis in
      patients who underwent distal pancreatic resection.
The development of sophisticated surgical procedures, improved postoperative care, and the
      capacity for early diagnosis of disease, have prolonged life expectancy after pancreatic
      resection. For these patients, the endocrine function of the pancreas is a critical factor
      that influences quality of life. In this study, the investigators recruit patients who
      underwent distal pancreatectomy in Peking Union Medical College Hospital within the last 10
      years. Demographic characteristics, operative parameters and short-term postoperative
      outcomes were collected in a prospective database maintained by the Pancreatic Surgical
      Centre, Peking Union Medical College Hospital. These patients are followed up regularly by
      outpatient visiting or telephone for long-term outcomes. The primary outcome of this study is
      new-onset diabetes mellitus; second outcomes include impaired fasting glucose, impaired
      glucose tolerance, exocrine insufficiency and disease recurrence. This study aim to determine
      the cumulative rates of endocrine insufficiency, and identify risk factors for DM development
      in a large cohort of patients undergoing distal pancreatectomy.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association
time frame: Through study completion, an average of 3 year
description: The criteria for the diagnosis of diabetes developed by American Diabetes Association (1) FPG (fasting plasma glucose) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.* OR (2) 2-h PG (plasma glucose) ≥ 200 mg/dL (11.1mmol/L) during an OGTT (oral glucose tolerance test). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.* OR (3) A1C ≥ 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.* (lower-upper limit: 4.5%-6.3% in PUMCH) OR (4) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).
*In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing.
measure: Number of participants with new-onset prediabetes as defined by American Diabetes Association
time frame: Through study completion, an average of 3 year
description: The categories of prediabetes (increased risk for diabetes)
(1) Impaired fasting glucose (IFG): FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L). (3.6 - 6.1 mmol/L in PUMCH) OR (2) Impaired glucose tolerance (IGT): 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.
OR (3) A1C 5.7-6.4% (39-46 mmol/mol)
measure: Number of participants with new-onset exocrine insufficiency
time frame: Through study completion, an average of 3 year
description: Exocrine insufficiency is defined as patients requiring oral pancreatic enzyme replacement because of severe diarrhea.
arm group label: Distal Pancreatectomy
description: Patients undergoing distal pancreatectomy
intervention type: Procedure
intervention name: Distal pancreatectomy
description: Distal pancreatectomy with or without splenectomy using minimal invasive or open approach
arm group label: Distal Pancreatectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Menghua Dai, M.D.
role: Study Chair
affiliation: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
facility: 
country: China
citation: Kwon JH, Kim SC, Shim IK, Song KB, Lee JH, Hwang DW, Park KM, Lee YJ. Factors Affecting the Development of Diabetes Mellitus After Pancreatic Resection. Pancreas. 2015 Nov;44(8):1296-303. doi: 10.1097/MPA.0000000000000404.
PMID: 26390413
citation: Shirakawa S, Matsumoto I, Toyama H, Shinzeki M, Ajiki T, Fukumoto T, Ku Y. Pancreatic volumetric assessment as a predictor of new-onset diabetes following distal pancreatectomy. J Gastrointest Surg. 2012 Dec;16(12):2212-9. doi: 10.1007/s11605-012-2039-7. Epub 2012 Sep 28.
PMID: 23054900
citation: King J, Kazanjian K, Matsumoto J, Reber HA, Yeh MW, Hines OJ, Eibl G. Distal pancreatectomy: incidence of postoperative diabetes. J Gastrointest Surg. 2008 Sep;12(9):1548-53. doi: 10.1007/s11605-008-0560-5. Epub 2008 Jun 10.
PMID: 18543045
citation: You DD, Choi SH, Choi DW, Heo JS, Ho CY, Kim WS. Long-term effects of pancreaticoduodenectomy on glucose metabolism. ANZ J Surg. 2012 Jun;82(6):447-51. doi: 10.1111/j.1445-2197.2012.06080.x. Epub 2012 May 9.
PMID: 22571457
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: Undecided