<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/NCT03028181</url>
  </required_header>
  <id_info>
    <org_study_id>896-000-57-79</org_study_id>
    <nct_id>NCT03028181</nct_id>
  </id_info>
  <brief_title>The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Pancreatic Disease</brief_title>
  <official_title>The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Acute Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wroclaw Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wroclaw Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to assess and analyze some selected antioxidants and laboratory parameters&#xD;
      during hospitalization of the patients with acute pancreatitis. It will allow to better&#xD;
      understanding of the mechanisms of disease and the development of better diagnostic,&#xD;
      treatment and monitoring.&#xD;
&#xD;
      It is an observational diagnostic study and does not involve any additional administration of&#xD;
      medicinal substances, modification of treatment or dropping the use of routine methods of&#xD;
      treatment of a disease. The study procedure includes detailed personal medical history as&#xD;
      separate document like as a routine medical interview, and three times taking a small amount&#xD;
      of venous blood (together about 15 ml), in the first, third, and seventh day of&#xD;
      hospitalization (in the case of longer hospital treatment).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pro-inflammatory effect of tobacco smoke exposure measured by hsCRP concentration in the blood of patients with acute pancreatitis</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pro-inflammatory effect of tobacco smoke exposure measured by Interleukin-6 concentration in the blood of patients with acute pancreatitis</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The estimation of antioxidant status measured by the activities of antioxidant enzymes in the blood</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The estimation of antioxidant status measured by small molecular antioxidants concentration in the blood</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The estimation of prooxidant status measured by the concentration of lipids peroxidation products in the blood</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The estimation of prooxidant status measured by the concentration of advanced oxidation protein products in the blood</measure>
    <time_frame>1 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The estimation of the concentration of vascular endothelium damage marker (endothelin) in the blood</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of the concentration of total cholesterol in the blood</measure>
    <time_frame>3 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of the concentration of triglycerides in the blood</measure>
    <time_frame>3 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of the concentration of low-density lipoprotein (LDL) in the blood</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of the concentration of high-density lipoprotein (HDL) in the blood</measure>
    <time_frame>3 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of endocrine functions of pancreas measured by the concentration of insulin in the blood</measure>
    <time_frame>2 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of endocrine functions of pancreas measured by the concentration of glucagon in the blood</measure>
    <time_frame>1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of endocrine functions of pancreas measured by the concentration of pancreatic polypeptide in the blood</measure>
    <time_frame>1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of endocrine functions of pancreas measured by the concentration of somatostatin in the blood</measure>
    <time_frame>1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of endocrine functions of pancreas measured by the concentration of ghrelin in the blood</measure>
    <time_frame>2 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The estimation of exocrine functions of pancreas measured by the activity of amylase and lipase in the blood</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Control group non-exposed to tobacco smoking</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>Control group exposed to tobacco smoking</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <description>Patients with acute pancreatitis non-exposed to tobacco smoking</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <description>Patients with acute pancreatitis exposed to tobacco smoking</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The blood samples taking into tubes containing heparin, EDTA and serum clotting activator to&#xD;
      obtain plasma, erythrocyte lysate and serum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. The healthy volunteers classified as a control group based on the research conducted&#xD;
             by clinicians of primary medical care, divided on smokers and non-smokers.&#xD;
&#xD;
          2. The patients classified into the group of patients with acute pancreatitis, divided on&#xD;
             smokers and non-smokers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients were classified into the group of patients with acute pancreatitis (AP)&#xD;
             due to clinical symptoms (acute onset of a persistent, severe, epigastric pain with&#xD;
             tenderness on palpation on physical examination), personal interview and clinical&#xD;
             method used in the diagnosis of pancreatitis - laboratory tests (elevation in serum&#xD;
             lipase or amylase to three times or greater than the upper limit of normal) and&#xD;
             characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed&#xD;
             tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography).&#xD;
             In patients with characteristic abdominal pain and elevation in serum lipase or&#xD;
             amylase to three times or greater than the upper limit of normal, no imaging was&#xD;
             required to establish the diagnosis of acute pancreatitis. In patients with abdominal&#xD;
             pain that was not characteristic for acute pancreatitis or serum amylase or lipase&#xD;
             levels that were less than three times the upper limit of normal, or in whom the&#xD;
             diagnosis was uncertain, the investigators performed abdominal imaging with a&#xD;
             contrast-enhanced abdominal CT scan to establish the diagnosis of acute pancreatitis&#xD;
             and to exclude other causes of acute abdominal pain. In patients with severe contrast&#xD;
             allergy or renal failure, the investigators performed an abdominal MRI without&#xD;
             gadolinium.&#xD;
&#xD;
          -  The volunteers classified as healthy based on the research conducted by clinicians of&#xD;
             primary medical care (control group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other accompanied diseases than acute pancreatitis (the patients groups)&#xD;
&#xD;
          -  Individuals of the control group with diagnosed disease as well as alcohol and drugs&#xD;
             abusers&#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_official>
    <last_name>Halina Milnerowicz, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Wroclaw Medical University, Wroclaw, Poland</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wroclaw Medical University</investigator_affiliation>
    <investigator_full_name>Milena Ściskalska</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>smoke</keyword>
  <keyword>acute pancreatitis</keyword>
  <keyword>pro/antioxidant status</keyword>
  <keyword>pro-inflammatory factors</keyword>
  <keyword>lipid profile</keyword>
  <keyword>exocrine functions of pancreas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03028181
org study id: 896-000-57-79
nct id: NCT03028181
lead sponsor: 
has dmc: No
The study aims to assess and analyze some selected antioxidants and laboratory parameters
      during hospitalization of the patients with acute pancreatitis. It will allow to better
      understanding of the mechanisms of disease and the development of better diagnostic,
      treatment and monitoring.

      It is an observational diagnostic study and does not involve any additional administration of
      medicinal substances, modification of treatment or dropping the use of routine methods of
      treatment of a disease. The study procedure includes detailed personal medical history as
      separate document like as a routine medical interview, and three times taking a small amount
      of venous blood (together about 15 ml), in the first, third, and seventh day of
      hospitalization (in the case of longer hospital treatment).
observational model: Other
time perspective: Retrospective
measure: Pro-inflammatory effect of tobacco smoke exposure measured by hsCRP concentration in the blood of patients with acute pancreatitis
time frame: 3 weeks
measure: Pro-inflammatory effect of tobacco smoke exposure measured by Interleukin-6 concentration in the blood of patients with acute pancreatitis
time frame: 2 weeks
measure: The estimation of antioxidant status measured by the activities of antioxidant enzymes in the blood
time frame: 12 months
measure: The estimation of antioxidant status measured by small molecular antioxidants concentration in the blood
time frame: 3 months
measure: The estimation of prooxidant status measured by the concentration of lipids peroxidation products in the blood
time frame: 2 months
measure: The estimation of prooxidant status measured by the concentration of advanced oxidation protein products in the blood
time frame: 1 months
measure: The estimation of the concentration of vascular endothelium damage marker (endothelin) in the blood
time frame: 3 months
measure: The estimation of the concentration of total cholesterol in the blood
time frame: 3 weeks
measure: The estimation of the concentration of triglycerides in the blood
time frame: 3 weeks
measure: The estimation of the concentration of low-density lipoprotein (LDL) in the blood
time frame: 3 months
measure: The estimation of the concentration of high-density lipoprotein (HDL) in the blood
time frame: 3 weeks
measure: The estimation of endocrine functions of pancreas measured by the concentration of insulin in the blood
time frame: 2 months
measure: The estimation of endocrine functions of pancreas measured by the concentration of glucagon in the blood
time frame: 1 month
measure: The estimation of endocrine functions of pancreas measured by the concentration of pancreatic polypeptide in the blood
time frame: 1 month
measure: The estimation of endocrine functions of pancreas measured by the concentration of somatostatin in the blood
time frame: 1 month
measure: The estimation of endocrine functions of pancreas measured by the concentration of ghrelin in the blood
time frame: 2 weeks
measure: The estimation of exocrine functions of pancreas measured by the activity of amylase and lipase in the blood
time frame: 3 months
arm group label: 1
description: Control group non-exposed to tobacco smoking
arm group label: 2
description: Control group exposed to tobacco smoking
arm group label: 3
description: Patients with acute pancreatitis non-exposed to tobacco smoking
arm group label: 4
description: Patients with acute pancreatitis exposed to tobacco smoking
The blood samples taking into tubes containing heparin, EDTA and serum clotting activator to
      obtain plasma, erythrocyte lysate and serum.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Halina Milnerowicz, Prof.
role: Study Chair
affiliation: Wroclaw Medical University, Wroclaw, Poland
responsible party type: Principal Investigator
investigator affiliation: Wroclaw Medical University
investigator full name: Milena Ściskalska
investigator title: Principal Investigator
mesh term: Pancreatitis
sharing ipd: No