<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/NCT01701830</url>
  </required_header>
  <id_info>
    <org_study_id>2012/02</org_study_id>
    <nct_id>NCT01701830</nct_id>
  </id_info>
  <brief_title>Serum Omentin-1 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease</brief_title>
  <official_title>The Relationship Between Serum Omentin-1 and IL-6 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli Derince Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli Derince Education and Research Hospital</source>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate whether a low level of serum omentin-1 is associated with&#xD;
      carotid atherosclerosis and mediated by inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atherosclerotic cardiovascular disease is markedly increased in chronic kidney disease. There&#xD;
      are a lot of risk factor, along with conventional risk factors. Serum onemtin-1 is a&#xD;
      adipokine and suggested as a new marker for vascular disease.It has some anti-atherogenic&#xD;
      properties. Studies investigating serum omentin-1 level have usually conducted in patients&#xD;
      with diabetes mellitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">May 2013</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">85</enrollment>
  <condition>Non-diabetic Chronic Kidney Disease</condition>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Case Group</arm_group_label>
    <description>Patients with chronic kidney disease of stage 3-4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>30 healthy subject</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Department of Nephrology, Check-up clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between ages of 18 - 65 years old chronic kidney disease of stage 3-4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic kidney disease of stage 5&#xD;
&#xD;
          -  The history of ischemic cardiovascular disease (myocardial infarction, unstable&#xD;
             angina, stroke, peripheral artery disease, or cardiovascular revascularization)&#xD;
&#xD;
          -  Severe heart failure&#xD;
&#xD;
          -  Stage 2 hypertension&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Corticosteroid therapy&#xD;
&#xD;
          -  Severe hepatic disease&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Inflammatory disease&#xD;
&#xD;
          -  Acute infectious disease&#xD;
&#xD;
          -  Malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erkan SENGUL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kocaeli Derince Education and Training Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nephrology, Check-up Clinic,Kocaeli Derince Education and Traning Hospital</name>
      <address>
        <city>Izmit</city>
        <state>Kocaeli</state>
        <zip>41100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rabia TERZI, MD</last_name>
      <phone>90262 317 80 00</phone>
      <phone_ext>8110</phone_ext>
      <email>drrabia1@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Erkan SENGUL, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gokhan DUYGULU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sevim DINDAR, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fatih BUNUL, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 4, 2012</last_update_submitted>
  <last_update_submitted_qc>October 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>omentin-1</keyword>
  <keyword>carotid atherosclerosis</keyword>
  <keyword>kidney disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Atherosclerosis</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/NCT01701830
org study id: 2012/02
nct id: NCT01701830
lead sponsor: 
The aim of the study is to evaluate whether a low level of serum omentin-1 is associated with
      carotid atherosclerosis and mediated by inflammation.
Atherosclerotic cardiovascular disease is markedly increased in chronic kidney disease. There
      are a lot of risk factor, along with conventional risk factors. Serum onemtin-1 is a
      adipokine and suggested as a new marker for vascular disease.It has some anti-atherogenic
      properties. Studies investigating serum omentin-1 level have usually conducted in patients
      with diabetes mellitus.
observational model: Case-Control
time perspective: Cross-Sectional
arm group label: Case Group
description: Patients with chronic kidney disease of stage 3-4.
arm group label: Control group
description: 30 healthy subject
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erkan SENGUL, MD
role: Principal Investigator
affiliation: Kocaeli Derince Education and Training Hospital
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Turkey
responsible party type: Sponsor
mesh term: Carotid Artery Diseases
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Atherosclerosis