<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/NCT03283644</url>
  </required_header>
  <id_info>
    <org_study_id>ERN_13-0355</org_study_id>
    <nct_id>NCT03283644</nct_id>
  </id_info>
  <brief_title>Obesity-related Inflammation in Patients Prior to and After Bariatric Surgery</brief_title>
  <official_title>Obesity-related Inflammation in Patients Prior to and After Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Birmingham NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Birmingham</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>
      This study investigates the chronic long-term health condition of obesity and its effect on&#xD;
      neutrophil function and the inflammatory response&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inflammation is a central component of the immune response. In its acute form it aids the&#xD;
      transition from disease to health via the activation of numerous immune cells, enabling them&#xD;
      to reach the site of infection/injury and orchestrate themselves to combat pathogens,&#xD;
      facilitating resolution and repair to restore the host to health. However, chronic&#xD;
      inflammation is deleterious to the host and differs from the &quot;classical&quot; acute inflammatory&#xD;
      process in that the inflammation is not necessarily so readily obvious and is not&#xD;
      self-limiting; rather, the immune system is in a constant state of low-grade activation and&#xD;
      when challenged by pathogenic or sterile injury the response is heightened, resulting in&#xD;
      prolonged tissue damage and a failure of efficient resolution mechanisms.&#xD;
&#xD;
      Neutrophils are important mediators of acquired innate immune responses but may also&#xD;
      contribute to the pathogenesis of chronic inflammatory diseases. Neutrophils are heavily&#xD;
      involved in antimicrobial defence; their primary role is the localisation and elimination of&#xD;
      pathogenic microorganisms. This, combined with their relatively short lifespan, has resulted&#xD;
      in a traditional view of them as limited &quot;kamikaze&quot; cells. However, as detailed here,&#xD;
      neutrophils have been shown to act with complexity and sophistication, orchestrating the&#xD;
      immune/inflammatory response but also inadvertently contributing to tissue damage in&#xD;
      different disease states. This study investigates the chronic long-term health condition of&#xD;
      obesity and its effect on neutrophil function and the inflammatory response&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">October 28, 2016</completion_date>
  <primary_completion_date type="Actual">August 28, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemical Markers associated with Inflamation</measure>
    <time_frame>OCT 2016</time_frame>
    <description>(IL-8, IL-1, ROS, Production of NETS)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Obesity</condition>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Patients with a BMI over 40</arm_group_label>
    <description>Participants were aged between 27-65 years, BMI &gt;40 , Co-Morbidities associated with obesity including sleep apnoea, hypertension, depression, hypercholesterolaemia and type 2 diabetes, Undergoing Gastric Band surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lean, healthy individuals</arm_group_label>
    <description>Participants were aged between 27-65 years, BMI&lt;28 , Systemically healthy, taking no prescribed medication</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Two study populations: Healthy control defined as systemically healthy and not taking&#xD;
        medication or supplements with a BMI less than 27; Bariatric participants who fit the&#xD;
        inclusion and exclusion criteria, but may also present with co-morbidities associated with&#xD;
        obesity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Bariatric participants:&#xD;
&#xD;
          -  BMI &gt;40&#xD;
&#xD;
          -  Undergoing Gastric Band surgery&#xD;
&#xD;
        Exclusion Bariatric Participants Criteria:&#xD;
&#xD;
          -  Undergoing alternative weight loss surgery&#xD;
&#xD;
          -  BMI&lt;40&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
        Exclusion criteria for the controls&#xD;
&#xD;
          -  BMI over 27&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  evidence of systemic disease&#xD;
&#xD;
          -  use of medications/vitamin supplements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>February 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric bypass</keyword>
  <keyword>Obesity</keyword>
  <keyword>Morbid obesity</keyword>
  <keyword>Matched Healthy Controls</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Inflammation</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/NCT03283644
org study id: ERN_13-0355
nct id: NCT03283644
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the chronic long-term health condition of obesity and its effect on
      neutrophil function and the inflammatory response
Inflammation is a central component of the immune response. In its acute form it aids the
      transition from disease to health via the activation of numerous immune cells, enabling them
      to reach the site of infection/injury and orchestrate themselves to combat pathogens,
      facilitating resolution and repair to restore the host to health. However, chronic
      inflammation is deleterious to the host and differs from the "classical" acute inflammatory
      process in that the inflammation is not necessarily so readily obvious and is not
      self-limiting; rather, the immune system is in a constant state of low-grade activation and
      when challenged by pathogenic or sterile injury the response is heightened, resulting in
      prolonged tissue damage and a failure of efficient resolution mechanisms.

      Neutrophils are important mediators of acquired innate immune responses but may also
      contribute to the pathogenesis of chronic inflammatory diseases. Neutrophils are heavily
      involved in antimicrobial defence; their primary role is the localisation and elimination of
      pathogenic microorganisms. This, combined with their relatively short lifespan, has resulted
      in a traditional view of them as limited "kamikaze" cells. However, as detailed here,
      neutrophils have been shown to act with complexity and sophistication, orchestrating the
      immune/inflammatory response but also inadvertently contributing to tissue damage in
      different disease states. This study investigates the chronic long-term health condition of
      obesity and its effect on neutrophil function and the inflammatory response
observational model: Case-Control
time perspective: Prospective
measure: Biochemical Markers associated with Inflamation
time frame: OCT 2016
description: (IL-8, IL-1, ROS, Production of NETS)
arm group label: Patients with a BMI over 40
description: Participants were aged between 27-65 years, BMI >40 , Co-Morbidities associated with obesity including sleep apnoea, hypertension, depression, hypercholesterolaemia and type 2 diabetes, Undergoing Gastric Band surgery
arm group label: Lean, healthy individuals
description: Participants were aged between 27-65 years, BMI<28 , Systemically healthy, taking no prescribed medication
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Obesity
mesh term: Obesity, Morbid
mesh term: Inflammation
sharing ipd: No