<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/NCT02264600</url>
  </required_header>
  <id_info>
    <org_study_id>AWED-31014</org_study_id>
    <nct_id>NCT02264600</nct_id>
  </id_info>
  <brief_title>Apelin in Willis Ekbom Disease</brief_title>
  <official_title>Oxidative Stress and Apelin Level in Willis Ekbom Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease&#xD;
      (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been&#xD;
      reported in recent studies. Increased oxidative stress is thought to play an important role&#xD;
      in cardiovascular complications of WED patients. Apelin is a novel described antioxidant&#xD;
      bioactive peptide. The investigators hypothesize that patients with WED have lower plasma&#xD;
      apelin level than healthy subjects based on presence of oxidative stress of WED.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">April 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>Serum apelin level in WED patients and healthy controls</measure>
    <time_frame>Two months</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Restless Legs Syndrome</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are administered to Kayseri Acibadem Hospital Sleep Medicine Unit, outpatient&#xD;
        clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed as RLS/WED according to International Classification of Sleep&#xD;
             Disorders (ICSD-3) criteria&#xD;
&#xD;
          -  Patients with idiopathic RLS/WED&#xD;
&#xD;
          -  Moderate and severe RLS/WED according to International Restless Legs Syndrome Rating&#xD;
             Scale&#xD;
&#xD;
          -  Periodic Leg Movements Index above 5 in polysomnography record&#xD;
&#xD;
          -  BMI below 25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disorders which cause symptomatic RLS(Iron deficiency anemia, kidney failure, diabetes&#xD;
             mellitus, pregnancy, Parkinson's disease, multiple sclerosis, neuropathy)&#xD;
&#xD;
          -  Systemic diseases which cause possible oxidative stress status (cardiovascular&#xD;
             diseases, obesity, diabetes mellitus, use of any medical drugs especially ACE&#xD;
             inhibitors e.g.)&#xD;
&#xD;
          -  Another sleep disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murat Aksu, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Acibadem University Faculty of Medicine, School of Electroneurophysiology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Selda Korkmaz, Assist. Prof. Dr.</last_name>
    <phone>00905325807889</phone>
    <email>korkmazs78@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tugce Bilecenoglu, M.D.</last_name>
    <phone>00905386275515</phone>
    <email>nedimetugche@yahoo.com</email>
  </overall_contact_backup>
  <link>
    <url>http://www.rls.org</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Cikrikcioglu MA, Hursitoglu M, Erkal H, Kinas BE, Sztajzel J, Cakirca M, Arslan AG, Erek A, Halac G, Tukek T. Oxidative stress and autonomic nervous system functions in restless legs syndrome. Eur J Clin Invest. 2011 Jul;41(7):734-42. doi: 10.1111/j.1365-2362.2010.02461.x. Epub 2011 Jan 20.</citation>
    <PMID>21250984</PMID>
  </reference>
  <reference>
    <citation>Baskol G, Korkmaz S, Erdem F, Caniklioglu A, Kocyigit M, Aksu M. Assessment of nitric oxide, advanced oxidation protein products, malondialdehyde, and thiol levels in patients with restless legs syndrome. Sleep Med. 2012 Apr;13(4):414-8. doi: 10.1016/j.sleep.2011.11.012.</citation>
    <PMID>22469072</PMID>
  </reference>
  <reference>
    <citation>Boucher J, Masri B, Daviaud D, Gesta S, Guigne C, Mazzucotelli A, Castan-Laurell I, Tack I, Knibiehler B, Carpene C, Audigier Y, Saulnier-Blache JS, Valet P. Apelin, a newly identified adipokine up-regulated by insulin and obesity. Endocrinology. 2005 Apr;146(4):1764-71. doi: 10.1210/en.2004-1427. Epub 2005 Jan 27.</citation>
    <PMID>15677759</PMID>
  </reference>
  <reference>
    <citation>Lv SY, Qin YJ, Wang HT, Xu N, Yang YJ, Chen Q. Centrally administered apelin-13 induces depression-like behavior in mice. Brain Res Bull. 2012 Sep 1;88(6):574-80. doi: 10.1016/j.brainresbull.2012.06.003. Epub 2012 Jun 21.</citation>
    <PMID>22728209</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 10, 2014</last_update_submitted>
  <last_update_submitted_qc>October 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Acibadem University</investigator_affiliation>
    <investigator_full_name>Selda Korkmaz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Restless Legs Syndrome, Apelin, Oxidative Stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Agitation</mesh_term>
    <mesh_term>Restless Legs Syndrome</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/NCT02264600
org study id: AWED-31014
nct id: NCT02264600
lead sponsor: 
has dmc: No
The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease
      (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been
      reported in recent studies. Increased oxidative stress is thought to play an important role
      in cardiovascular complications of WED patients. Apelin is a novel described antioxidant
      bioactive peptide. The investigators hypothesize that patients with WED have lower plasma
      apelin level than healthy subjects based on presence of oxidative stress of WED.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Serum apelin level in WED patients and healthy controls
time frame: Two months
Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Murat Aksu, Prof. Dr.
role: Study Director
affiliation: Acibadem University Faculty of Medicine, School of Electroneurophysiology
last name: Selda Korkmaz, Assist. Prof. Dr.
phone: 00905325807889
email: korkmazs78@gmail.com
last name: Tugce Bilecenoglu, M.D.
phone: 00905386275515
email: nedimetugche@yahoo.com
url: http://www.rls.org
description: Related Info
citation: Cikrikcioglu MA, Hursitoglu M, Erkal H, Kinas BE, Sztajzel J, Cakirca M, Arslan AG, Erek A, Halac G, Tukek T. Oxidative stress and autonomic nervous system functions in restless legs syndrome. Eur J Clin Invest. 2011 Jul;41(7):734-42. doi: 10.1111/j.1365-2362.2010.02461.x. Epub 2011 Jan 20.
PMID: 21250984
citation: Baskol G, Korkmaz S, Erdem F, Caniklioglu A, Kocyigit M, Aksu M. Assessment of nitric oxide, advanced oxidation protein products, malondialdehyde, and thiol levels in patients with restless legs syndrome. Sleep Med. 2012 Apr;13(4):414-8. doi: 10.1016/j.sleep.2011.11.012.
PMID: 22469072
citation: Boucher J, Masri B, Daviaud D, Gesta S, Guigne C, Mazzucotelli A, Castan-Laurell I, Tack I, Knibiehler B, Carpene C, Audigier Y, Saulnier-Blache JS, Valet P. Apelin, a newly identified adipokine up-regulated by insulin and obesity. Endocrinology. 2005 Apr;146(4):1764-71. doi: 10.1210/en.2004-1427. Epub 2005 Jan 27.
PMID: 15677759
citation: Lv SY, Qin YJ, Wang HT, Xu N, Yang YJ, Chen Q. Centrally administered apelin-13 induces depression-like behavior in mice. Brain Res Bull. 2012 Sep 1;88(6):574-80. doi: 10.1016/j.brainresbull.2012.06.003. Epub 2012 Jun 21.
PMID: 22728209
responsible party type: Principal Investigator
investigator affiliation: Acibadem University
investigator full name: Selda Korkmaz
investigator title: Principal Investigator
mesh term: Psychomotor Agitation
mesh term: Restless Legs Syndrome