xml: <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/NCT05989867</url>
    </required_header>
    <id_info>
      <org_study_id>ESTABLISH</org_study_id>
      <nct_id>NCT05989867</nct_id>
    </id_info>
    <brief_title>Evaluation of OGTT in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization</brief_title>
    <official_title>Evaluation of Oral Glucose Tolerance Testing in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization: a Cross-sectional Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changhai 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>
        To evaluate the islet function and insulin secretion pattern of post-pancreatitis diabetes&#xD;
        mellitus by oral glucose tolerance testing, and to explore the pathophysiological&#xD;
        characteristics of PPDM-C which provide evidence for the diagnosis of PPDM-C.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Blood samples will be collected from patients with chronic pancreatitis by oral glucose&#xD;
        tolerance test (steamed bun meal test, SBMT) to assess their pancreatic islet function and&#xD;
        insulin secretion pattern, measure other intestinal hormones, exosomes, plasma metabolites,&#xD;
        and serum biochemical factors to characterize the pathophysiological features of PPDM-C and&#xD;
        provide evidence for the diagnosis of PPDM-C. In order to better understand the glycemic&#xD;
        fluctuations in patients with chronic pancreatitis combined with diabetes and guide&#xD;
        subsequent treatment, Continuous Glucose Monitoring would be used in patients with chronic&#xD;
        pancreatitis who had new-onset diabetes or poor glycemic control.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>steamed bun meal test result 1</measure>
      <time_frame>Within 5 hours after the end of the steamed bread meal test</time_frame>
      <description>Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>steamed bun meal test result 2</measure>
      <time_frame>Within 6 hours after the end of the steamed bread meal test</time_frame>
      <description>Levels of c-peptide bun meal experiment (100g flour made steamed bun)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>steamed bun meal test result 3</measure>
      <time_frame>Within 7 hours after the end of the steamed bread meal test</time_frame>
      <description>Levels of insulin under the steamed bun meal experiment (100g flour made steamed bun)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>gut hormone</measure>
      <time_frame>up to 1 month</time_frame>
      <description>Levels of gut hormone under the steamed bun meal experiment (100g flour made steamed bun)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Continuous glucose monitor results</measure>
      <time_frame>after using continuous glucose monitor device for 7-14 days</time_frame>
      <description>Time to target range (TIR) : the proportion of time with blood glucose fluctuation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>glycemic control</measure>
      <time_frame>at the time of enrollment</time_frame>
      <description>glycosylated hemoglobin（%）</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Chronic Pancreatitis</condition>
    <condition>Pancreatogenic Type 3C Diabetes Mellitus</condition>
    <condition>Diabetes Mellitus</condition>
    <condition>Oral Glucose Tolerance Test</condition>
    <arm_group>
      <arm_group_label>CP</arm_group_label>
      <description>patients with chronic pancreatitis but not combined with diabetes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PPDM-C</arm_group_label>
      <description>patients with post-chronic pancreatitis diabetes mellitus</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CP+IGT</arm_group_label>
      <description>patients with chronic pancreatitis combined with impaired glucose tolerance</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CP+T2DM</arm_group_label>
      <description>patients with chronic pancreatitis combined with type 2 diabetes mellitus</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>blood test</intervention_name>
      <description>Evaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis.&#xD;
  Characterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors</description>
      <arm_group_label>CP</arm_group_label>
      <arm_group_label>CP+IGT</arm_group_label>
      <arm_group_label>CP+T2DM</arm_group_label>
      <arm_group_label>PPDM-C</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Continuous Glucose Monitor</intervention_name>
      <description>blood glucose will be monitored 24 hours a day from 7 to 14 days by wearing continuous glucose monitor(only for patients who had new-onset diabetes or poor glycemic control )</description>
      <arm_group_label>CP+IGT</arm_group_label>
      <arm_group_label>CP+T2DM</arm_group_label>
      <arm_group_label>PPDM-C</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with chronic pancreatitis treated in the Department of Gastroenterology of&#xD;
          Changhai Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 15-85&#xD;
  &#xD;
            2. patients with the diagnosis of chronic pancreatitis and diabetes mellitus (exclude&#xD;
               type 1 diabetes).&#xD;
  &#xD;
            3. participants with painless chronic pancreatitis were diagnosed with diabetes within 2&#xD;
               years of the diagnosis of chronic pancreatitis.&#xD;
  &#xD;
            4. participants with painful chronic pancreatitis were diagnosed with diabetes after the&#xD;
               first attack of chronic pancreatitis.&#xD;
  &#xD;
            5. patients with chronic pancreatitis were previously diagnosed type 2 diabetes mellitus&#xD;
               for more than 3 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants with suspected malignant tumors of the pancreas or other sites of the&#xD;
               body (including pancreatic cyst and Benign pancreatic tumor), or participants in the&#xD;
               terminal stage of severe disease&#xD;
  &#xD;
            2. Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy,&#xD;
               distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or&#xD;
               gastrointestinal surgery.&#xD;
  &#xD;
            3. Serious mental illness, lesion of the liver (alanine aminotransferase or aspartate&#xD;
               aminotransferase &gt; 3 times the upper reference limit) or kidney (eGFR&lt;60 mL/min/1.73&#xD;
               m2), pregnancy, breastfeeding or planning pregnancy, or accompanied with active liver&#xD;
               diseases such as hepatitis B or hepatic cirrhosis.&#xD;
  &#xD;
            4. Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose&#xD;
  &#xD;
            5. Using high-dose insulin preparations, or drugs affecting glucose metabolism (oral&#xD;
               steroids, thiazide diuretics, beta-blockers, beta-agonist, nicotinic acid,&#xD;
               immunosuppressant agents, antiretroviral drugs, and antipsychotics)&#xD;
  &#xD;
            6. Acute complications of diabetes (diabetic ketoacidosis, severe hypoglycemia), severe&#xD;
               microvascular disease (proliferative diabetic retinopathy, known diabetic nephropathy&#xD;
               or neuropathy requiring treatment), and macrovascular disease (uncontrolled arterial&#xD;
               hypertension, uncontrolled coronary artery disease, congestive heart failure, history&#xD;
               of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic&#xD;
               disease or atrial fibrillation) within the 12 months prior to enrollment.&#xD;
  &#xD;
            7. Hospitalization for acute pancreatitis within the 2 months prior to enrollment or&#xD;
               currently suffering acute inflammation.&#xD;
  &#xD;
            8. Have been enrolled or currently participating in other clinical trials within the 3&#xD;
               months prior to enrollment.&#xD;
  &#xD;
            9. Patients who refused to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zhuan Liao</last_name>
      <phone>13061921980</phone>
      <email>liaozhuan@smmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Gastroenterology, Changhai Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200433</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>zhuan liao, MD</last_name>
        <phone>86-21-31161004</phone>
        <email>liaozhuan@smmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Changhai Hospital</investigator_affiliation>
      <investigator_full_name>Zhuan Liao</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatitis</mesh_term>
      <mesh_term>Pancreatitis, Chronic</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989867
  org study id: ESTABLISH
  nct id: NCT05989867
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the islet function and insulin secretion pattern of post-pancreatitis diabetes
        mellitus by oral glucose tolerance testing, and to explore the pathophysiological
        characteristics of PPDM-C which provide evidence for the diagnosis of PPDM-C.
  Blood samples will be collected from patients with chronic pancreatitis by oral glucose
        tolerance test (steamed bun meal test, SBMT) to assess their pancreatic islet function and
        insulin secretion pattern, measure other intestinal hormones, exosomes, plasma metabolites,
        and serum biochemical factors to characterize the pathophysiological features of PPDM-C and
        provide evidence for the diagnosis of PPDM-C. In order to better understand the glycemic
        fluctuations in patients with chronic pancreatitis combined with diabetes and guide
        subsequent treatment, Continuous Glucose Monitoring would be used in patients with chronic
        pancreatitis who had new-onset diabetes or poor glycemic control.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: steamed bun meal test result 1
  time frame: Within 5 hours after the end of the steamed bread meal test
  description: Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)
  measure: steamed bun meal test result 2
  time frame: Within 6 hours after the end of the steamed bread meal test
  description: Levels of c-peptide bun meal experiment (100g flour made steamed bun)
  measure: steamed bun meal test result 3
  time frame: Within 7 hours after the end of the steamed bread meal test
  description: Levels of insulin under the steamed bun meal experiment (100g flour made steamed bun)
  measure: gut hormone
  time frame: up to 1 month
  description: Levels of gut hormone under the steamed bun meal experiment (100g flour made steamed bun)
  measure: Continuous glucose monitor results
  time frame: after using continuous glucose monitor device for 7-14 days
  description: Time to target range (TIR) : the proportion of time with blood glucose fluctuation
  measure: glycemic control
  time frame: at the time of enrollment
  description: glycosylated hemoglobin（%）
  arm group label: CP
  description: patients with chronic pancreatitis but not combined with diabetes
  arm group label: PPDM-C
  description: patients with post-chronic pancreatitis diabetes mellitus
  arm group label: CP+IGT
  description: patients with chronic pancreatitis combined with impaired glucose tolerance
  arm group label: CP+T2DM
  description: patients with chronic pancreatitis combined with type 2 diabetes mellitus
  intervention type: Diagnostic Test
  intervention name: blood test
  description: Evaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis.
  Characterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors
  arm group label: CP
  arm group label: CP+IGT
  arm group label: CP+T2DM
  arm group label: PPDM-C
  intervention type: Device
  intervention name: Continuous Glucose Monitor
  description: blood glucose will be monitored 24 hours a day from 7 to 14 days by wearing continuous glucose monitor(only for patients who had new-onset diabetes or poor glycemic control )
  arm group label: CP+IGT
  arm group label: CP+T2DM
  arm group label: PPDM-C
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Zhuan Liao
  phone: 13061921980
  email: liaozhuan@smmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Changhai Hospital
  investigator full name: Zhuan Liao
  investigator title: professor
  mesh term: Pancreatitis
  mesh term: Pancreatitis, Chronic
  mesh term: Diabetes Mellitus