<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/NCT01661127</url>
  </required_header>
  <id_info>
    <org_study_id>PNUHDM-psoriasis</org_study_id>
    <nct_id>NCT01661127</nct_id>
  </id_info>
  <brief_title>Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis</brief_title>
  <official_title>Phase 0 Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psoriasis is associated with increases in markers of inflammation in the skin and blood and&#xD;
      increasingly is thought to be a systemic inflammatory disease and risk factor for incident&#xD;
      diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death.&#xD;
      Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial&#xD;
      emotional impact on an individual, which is not necessarily related to the extent of skin&#xD;
      disease.&#xD;
&#xD;
      FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner&#xD;
      that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that&#xD;
      chronic disease such as end stage renal disease with depressive symptoms have decreased&#xD;
      cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was&#xD;
      designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of&#xD;
      cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms&#xD;
      in patients with psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      10 Patients with psoriasis&#xD;
&#xD;
        1. Evaluate PASI score&#xD;
&#xD;
        2. Evaluate comorbidity with metabolic syndrome&#xD;
&#xD;
             -  Body mass index(BMI)&#xD;
&#xD;
             -  Checking blood pressure&#xD;
&#xD;
             -  Checking blood sugar&#xD;
&#xD;
             -  Smoking and drinking history&#xD;
&#xD;
             -  Checking blood cholesterol level&#xD;
&#xD;
             -  Risk factors of cardiovascular disease&#xD;
&#xD;
        3. PET/CT for measuring the extent and site of psoriasis with inflammation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Beck depression inventory scoring and Korean Hamilton depression scale scoring</measure>
    <time_frame>Day 0 and 28 weeks later</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain glucose uptake using PET/CT</measure>
    <time_frame>Day 0 and 28 weeks later</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Psoriasis</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Depression</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral blood and 18-F-FDG PET/CT images&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of diagnosed with psoriasis in Pusan National University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of plaque type psoriasis&#xD;
&#xD;
          -  at least 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those who cannot understand questionnaire&#xD;
&#xD;
          -  those who take antidepressant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byung-Soo Kim, Ph D.</last_name>
    <role>Study Chair</role>
    <affiliation>Pusan National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Byung-Soo Kim, Ph D.</last_name>
    <phone>82-51-240-7338</phone>
    <email>dockbs@pusan.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of dermatology, Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Byung-Soo Kim, Ph D.</last_name>
      <phone>82-51-240-7338</phone>
      <email>dockbs@pusan.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>November 3, 2014</last_update_submitted>
  <last_update_submitted_qc>November 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT01661127
org study id: PNUHDM-psoriasis
nct id: NCT01661127
lead sponsor: 
has dmc: No
Psoriasis is associated with increases in markers of inflammation in the skin and blood and
      increasingly is thought to be a systemic inflammatory disease and risk factor for incident
      diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death.
      Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial
      emotional impact on an individual, which is not necessarily related to the extent of skin
      disease.

      FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner
      that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that
      chronic disease such as end stage renal disease with depressive symptoms have decreased
      cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was
      designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of
      cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms
      in patients with psoriasis.
10 Patients with psoriasis

        1. Evaluate PASI score

        2. Evaluate comorbidity with metabolic syndrome

             -  Body mass index(BMI)

             -  Checking blood pressure

             -  Checking blood sugar

             -  Smoking and drinking history

             -  Checking blood cholesterol level

             -  Risk factors of cardiovascular disease

        3. PET/CT for measuring the extent and site of psoriasis with inflammation
observational model: Case-Only
time perspective: Prospective
measure: Beck depression inventory scoring and Korean Hamilton depression scale scoring
time frame: Day 0 and 28 weeks later
measure: Brain glucose uptake using PET/CT
time frame: Day 0 and 28 weeks later
Peripheral blood and 18-F-FDG PET/CT images
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Byung-Soo Kim, Ph D.
role: Study Chair
affiliation: Pusan National University Hospital
last name: Byung-Soo Kim, Ph D.
phone: 82-51-240-7338
email: dockbs@pusan.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Depression