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/NCT06006312</url>
    </required_header>
    <id_info>
      <org_study_id>SHDC12021107</org_study_id>
      <nct_id>NCT06006312</nct_id>
    </id_info>
    <brief_title>Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests</brief_title>
    <official_title>Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ruijin Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Changhai 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>
        The goal of this observational study is to improve the epidemiological data of pancreatic&#xD;
        exocrine insufficiency in China, determine the FE-1 cut-off value for the classification of&#xD;
        PEI, and explore the characteristic differences between T3cDM and type 2 diabetes mellitus in&#xD;
        clinical symptoms and laboratory indicators.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pancreatic exocrine insufficiency (PEI) refers to the reduction in the synthesis and&#xD;
        secretion of pancreatic enzymes caused by various reasons, which leads to malabsorption and&#xD;
        even nutritional deficiencies. The main causes of PEI include chronic pancreatitis (CP),&#xD;
        acute pancreatitis, pancreatic cancer, pancreatectomy, enterectomy, diabetes mellitus and&#xD;
        cystic fibrosis. Due to its numerous etiologies, the current prevalence of PEI is uncertain&#xD;
        and very varied. The prevalence of PEI in the Chinese population is still lacking. Diagnosis&#xD;
        of PEI in clinical practice is hindered by the lack of accurate tests, and it usually&#xD;
        requires the combination of symptoms, nutritional markers and a noninvasive pancreatic&#xD;
        function test in the appropriate clinical context. At present, the fecal elastase-1 (FE-1)&#xD;
        test is the most widely applied non-invasive approach in routine clinical practice.&#xD;
  &#xD;
        First, the study plans to record the baseline data of participants and perform the FE-1 test&#xD;
        in specific elderly population and community population, in order to improve the epidemiology&#xD;
        of PEI in China.&#xD;
  &#xD;
        Second, the study will perform the FE-1 test in 100 CP patients, in order to determine the&#xD;
        FE-1 cut-off value for the classification of PEI (mild-moderate and severe), using the&#xD;
        coefficient of fat absorption as the &quot;gold standard&quot;.&#xD;
  &#xD;
        Third, people with CP often have diabetes mellitus which is described as type 3c diabetes&#xD;
        mellitus (T3cDM). However, there are no recognized diagnostic criteria for T3cDM. Studies&#xD;
        have shown that close to 50% of T3cDM cases are misclassified, most of which are diagnosed as&#xD;
        type 2 diabetes mellitus (T2DM). According to certain research, the early stages of T3cDM are&#xD;
        characterized by insufficient insulin and C-peptide secretion. The study will provide&#xD;
        laboratory testing to 300 patients with T3cDM and T2DM in order to compare the differences&#xD;
        and create T3cDM diagnostic criteria.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the prevalence of pancreatic exocrine insufficiency</measure>
      <time_frame>7 days after each participant collected stool samples</time_frame>
      <description>Prevalence of pancreatic exocrine insufficiency (mild-moderate, sever) which is dependent on FE-1 level assessment in elderly population and community population respectively.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Concentration of Glycosylated hemoglobin</measure>
      <time_frame>1 day after each participant collected blood sample</time_frame>
      <description>Compare the concentration of glycosylated hemoglobin in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of plasma glucose</measure>
      <time_frame>1 day after each participant collected blood sample</time_frame>
      <description>During oral glucose tolerance test, concentration of plasma glucose (fasting and 2-hour) will be measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-peptide level</measure>
      <time_frame>1 day after each participant collected blood sample</time_frame>
      <description>During oral glucose tolerance test, C-peptide levels (fasting and 2-hour) are measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin level</measure>
      <time_frame>1 day after each participant collected blood sample</time_frame>
      <description>During oral glucose tolerance test, insulin levels (fasting and 2-hour) are measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">2400</enrollment>
    <condition>Chronic Pancreatitis</condition>
    <condition>Pancreatic Exocrine Insufficiency</condition>
    <condition>Diabetes Mellitus</condition>
    <condition>Community Populations</condition>
    <condition>Fecal Elastase-1 Test</condition>
    <arm_group>
      <arm_group_label>Elderly population</arm_group_label>
      <description>The elderly population is defined as those over 60 years of age and residing in retirement home. Excluding people with critical conditions, mental disorders that prevent them from cooperating with the study, and those who are unable to defecate due to intestinal obstruction or other illnesses.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Community population</arm_group_label>
      <description>This group is the resident population of the community. Excluding people with critical conditions, mental disorders that prevent them from cooperating with the study, and those who are unable to defecate due to intestinal obstruction or other illnesses.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chronic pancreatitis</arm_group_label>
      <description>Patients with chronic pancreatitis are considered as study subjects. If a CP patient has diabetes mellitus (exclude type 1 diabetes mellitus), a blood test will be performed to assess glycemic control.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type 2 diabetes mellitus</arm_group_label>
      <description>Patients with type 2 diabetes mellitus are considered as study subjects.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>fecal elastase-1 test</intervention_name>
      <description>Personal information of the enrolled subjects will be collected and a fecal collection device will be distributed. Fecal elastase-1 levels will be measured after the fecal sample is collected.</description>
      <arm_group_label>Chronic pancreatitis</arm_group_label>
      <arm_group_label>Community population</arm_group_label>
      <arm_group_label>Elderly population</arm_group_label>
      <arm_group_label>Type 2 diabetes mellitus</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>72-hour fecal fat quantification</intervention_name>
      <description>Enrolled subjects will eat a standard meal (100g of fat) daily for five consecutive days and collect stool samples for the last 72h. The fat content in the sample will be quantitatively detected and the fat absorption coefficient will be calculated.</description>
      <arm_group_label>Chronic pancreatitis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>blood sample test</intervention_name>
      <description>The enrolled subjects will undergo oral glucose tolerance test and will be collected blood samples for measurement of plasma glucose, insulin level, C-peptide level, glycosylated hemoglobin and vitamin.</description>
      <arm_group_label>Chronic pancreatitis</arm_group_label>
      <arm_group_label>Type 2 diabetes mellitus</arm_group_label>
      <other_name>oral glucose tolerance test</other_name>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        feces&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Elderly participants will be recruited from several nursing homes. Community participants&#xD;
          will be recruited from the community in Shanghai, China. Patients whti chronic pancreatitis&#xD;
          and type 2 diabetes mellitus come from Changhai Hospital, Ruijin Hospital and Shanghai&#xD;
          General Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          For elderly population and community population:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            1. Agree to participate in the study and sign the informed consent.&#xD;
  &#xD;
            2. Age of elderly participants are over 60 years old and the participants from community&#xD;
               is unlimited.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants in critical condition.&#xD;
  &#xD;
            2. Have mental disorders and unable cooperate with investigators.&#xD;
  &#xD;
            3. Have received bladder replacement with ileocolon surgery, or have intestinal&#xD;
               obstruction and other diseases that can not defecate.&#xD;
  &#xD;
          For chronic pancreatitis patients:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with chronic pancreatitis.&#xD;
  &#xD;
            2. Age between 18 and 80 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or breastfeeding women&#xD;
  &#xD;
            2. Participants in critical condition.&#xD;
  &#xD;
            3. Have mental disorders and unable cooperate with investigators.&#xD;
  &#xD;
            4. Have received bladder replacement with ileocolon surgery, or have intestinal&#xD;
               obstruction and other diseases that can not defecate.&#xD;
  &#xD;
            5. Fecal sample quality, storage and transportation do not meet the requirements of fecal&#xD;
               elastase-1 test.&#xD;
  &#xD;
            6. Have undergone gastrectomy or pancreatectomy more than once.&#xD;
  &#xD;
          For chronic pancreatitis patients with diabetes and patients with type 2 diabetes mellitus:&#xD;
  &#xD;
          Inclusion Criteria (meet 1 or 2):&#xD;
  &#xD;
            1. Patients with chronic pancreatitis and diabetes mellitus.&#xD;
  &#xD;
            2. Patients with type 2 diabetes mellitus.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with type 2 diabetes mellitus.&#xD;
  &#xD;
            2. Participants in critical condition.&#xD;
  &#xD;
            3. Have mental disorders and unable cooperate with investigators.&#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>
    <overall_contact>
      <last_name>Liang-hao Hu, MD</last_name>
      <phone>+86-13817593520</phone>
      <email>lianghao-hu@smmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhao-shen Li, MD</last_name>
      <phone>+86-13901960921</phone>
      <email>zhaoshen-li@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Changhai Hospital</name>
        <address>
          <city>Shanghai</city>
          <zip>200433</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Liang-hao Hu, MD</last_name>
        <phone>+86-13817593520</phone>
        <email>lianghao-hu@smmu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Zhao-shen Li, MD</last_name>
        <phone>+86-13901960921</phone>
        <email>zhaoshen-li@hotmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Yi-li Cai</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Xiao-yu Zhou</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Xi He</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Changhai Hospital</investigator_affiliation>
      <investigator_full_name>Zhaoshen Li</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>Exocrine Pancreatic Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06006312
  org study id: SHDC12021107
  nct id: NCT06006312
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to improve the epidemiological data of pancreatic
        exocrine insufficiency in China, determine the FE-1 cut-off value for the classification of
        PEI, and explore the characteristic differences between T3cDM and type 2 diabetes mellitus in
        clinical symptoms and laboratory indicators.
  Pancreatic exocrine insufficiency (PEI) refers to the reduction in the synthesis and
        secretion of pancreatic enzymes caused by various reasons, which leads to malabsorption and
        even nutritional deficiencies. The main causes of PEI include chronic pancreatitis (CP),
        acute pancreatitis, pancreatic cancer, pancreatectomy, enterectomy, diabetes mellitus and
        cystic fibrosis. Due to its numerous etiologies, the current prevalence of PEI is uncertain
        and very varied. The prevalence of PEI in the Chinese population is still lacking. Diagnosis
        of PEI in clinical practice is hindered by the lack of accurate tests, and it usually
        requires the combination of symptoms, nutritional markers and a noninvasive pancreatic
        function test in the appropriate clinical context. At present, the fecal elastase-1 (FE-1)
        test is the most widely applied non-invasive approach in routine clinical practice.
  
        First, the study plans to record the baseline data of participants and perform the FE-1 test
        in specific elderly population and community population, in order to improve the epidemiology
        of PEI in China.
  
        Second, the study will perform the FE-1 test in 100 CP patients, in order to determine the
        FE-1 cut-off value for the classification of PEI (mild-moderate and severe), using the
        coefficient of fat absorption as the "gold standard".
  
        Third, people with CP often have diabetes mellitus which is described as type 3c diabetes
        mellitus (T3cDM). However, there are no recognized diagnostic criteria for T3cDM. Studies
        have shown that close to 50% of T3cDM cases are misclassified, most of which are diagnosed as
        type 2 diabetes mellitus (T2DM). According to certain research, the early stages of T3cDM are
        characterized by insufficient insulin and C-peptide secretion. The study will provide
        laboratory testing to 300 patients with T3cDM and T2DM in order to compare the differences
        and create T3cDM diagnostic criteria.
  observational model: Ecologic or Community
  time perspective: Cross-Sectional
  measure: the prevalence of pancreatic exocrine insufficiency
  time frame: 7 days after each participant collected stool samples
  description: Prevalence of pancreatic exocrine insufficiency (mild-moderate, sever) which is dependent on FE-1 level assessment in elderly population and community population respectively.
  measure: Concentration of Glycosylated hemoglobin
  time frame: 1 day after each participant collected blood sample
  description: Compare the concentration of glycosylated hemoglobin in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.
  measure: Concentration of plasma glucose
  time frame: 1 day after each participant collected blood sample
  description: During oral glucose tolerance test, concentration of plasma glucose (fasting and 2-hour) will be measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.
  measure: C-peptide level
  time frame: 1 day after each participant collected blood sample
  description: During oral glucose tolerance test, C-peptide levels (fasting and 2-hour) are measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.
  measure: Insulin level
  time frame: 1 day after each participant collected blood sample
  description: During oral glucose tolerance test, insulin levels (fasting and 2-hour) are measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.
  arm group label: Elderly population
  description: The elderly population is defined as those over 60 years of age and residing in retirement home. Excluding people with critical conditions, mental disorders that prevent them from cooperating with the study, and those who are unable to defecate due to intestinal obstruction or other illnesses.
  arm group label: Community population
  description: This group is the resident population of the community. Excluding people with critical conditions, mental disorders that prevent them from cooperating with the study, and those who are unable to defecate due to intestinal obstruction or other illnesses.
  arm group label: Chronic pancreatitis
  description: Patients with chronic pancreatitis are considered as study subjects. If a CP patient has diabetes mellitus (exclude type 1 diabetes mellitus), a blood test will be performed to assess glycemic control.
  arm group label: Type 2 diabetes mellitus
  description: Patients with type 2 diabetes mellitus are considered as study subjects.
  intervention type: Diagnostic Test
  intervention name: fecal elastase-1 test
  description: Personal information of the enrolled subjects will be collected and a fecal collection device will be distributed. Fecal elastase-1 levels will be measured after the fecal sample is collected.
  arm group label: Chronic pancreatitis
  arm group label: Community population
  arm group label: Elderly population
  arm group label: Type 2 diabetes mellitus
  intervention type: Diagnostic Test
  intervention name: 72-hour fecal fat quantification
  description: Enrolled subjects will eat a standard meal (100g of fat) daily for five consecutive days and collect stool samples for the last 72h. The fat content in the sample will be quantitatively detected and the fat absorption coefficient will be calculated.
  arm group label: Chronic pancreatitis
  intervention type: Diagnostic Test
  intervention name: blood sample test
  description: The enrolled subjects will undergo oral glucose tolerance test and will be collected blood samples for measurement of plasma glucose, insulin level, C-peptide level, glycosylated hemoglobin and vitamin.
  arm group label: Chronic pancreatitis
  arm group label: Type 2 diabetes mellitus
  other name: oral glucose tolerance test
  feces
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Liang-hao Hu, MD
  phone: +86-13817593520
  email: lianghao-hu@smmu.edu.cn
  last name: Zhao-shen Li, MD
  phone: +86-13901960921
  email: zhaoshen-li@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Changhai Hospital
  investigator full name: Zhaoshen Li
  investigator title: Professor
  mesh term: Pancreatitis
  mesh term: Pancreatitis, Chronic
  mesh term: Exocrine Pancreatic Insufficiency
  sharing ipd: No