<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/NCT03019679</url>
  </required_header>
  <id_info>
    <org_study_id>GaziosmanpasaU</org_study_id>
    <nct_id>NCT03019679</nct_id>
  </id_info>
  <brief_title>Serum Endocan Levels in Polycystic Ovary Syndrome</brief_title>
  <official_title>Serum Endocan Levels in Polycystic Ovary Syndrome: a Possible Marker of Angiogenic Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tokat Gaziosmanpasa University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tokat Gaziosmanpasa University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators aimed to investigate whether there is a relation between&#xD;
      polycystic ovary syndrome and serum endocan levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Polycystic ovary syndrome is a disorder which is associated with insulin resistance,&#xD;
      diabetes, obesity, and cardiovascular disease. Endothelial dysfunction, which is known to be&#xD;
      an early marker of atherosclerosis, has also been shown to have an association with poycystic&#xD;
      ovary syndrome. In this study the investigators aimed to investigate whether there is a&#xD;
      relation between polycystic ovary syndrome and serum endocan levels. For this purpose the&#xD;
      investigators designed a prospective study including two groups. The diagnosis of polycystic&#xD;
      ovary syndrome was made in the presence of ;oligo- and/or anovulation,clinical&#xD;
      hyperandrogenism and polycystic ovaries. Clinical hyperandrogenism was defined by the&#xD;
      presence of hirsutism , acne, or the presence of androgenic alopecia, body mass index (BMI)&#xD;
      was calculated as weight in kilograms divided by the square of height in meters. The two&#xD;
      groups are compared considering their serum endocan levels,follicle stimulating hormone&#xD;
      (FSH), luteinizing hormone (LH), Dihydroepiandesterone sulphate (DHEAS), total testesterone&#xD;
      (TT), estradiol (E2) and thyroid stimulating hormone (TSH), fasting blood glucose,&#xD;
      triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein, and&#xD;
      C-reactive protein (CRP) levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Serum endocan level and its relationship with Polycystic Ovary Syndrome</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">175</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Patients with polycystic ovary syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Patients without polycyctic ovary syndrome</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      serum samples,centrifuged&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        84 women with PCOS and 84 healty women as control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 45 years&#xD;
&#xD;
          -  Patients diagnosed with PCOS according to Rotterdam criteris (for the study group)&#xD;
&#xD;
          -  Patients without PCOS and menstrual irregularities (for the control group)&#xD;
&#xD;
          -  Absence of significant abnormalities on physical examination except hirsutism&#xD;
&#xD;
          -  No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy&#xD;
&#xD;
          -  Normal thyroid function and prolactin level&#xD;
&#xD;
          -  Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic&#xD;
             disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Ovarian tumors&#xD;
&#xD;
          -  Endocrine diseases (Cushing disease, 21-Hydroxylase enzyme deficiency, thyroid&#xD;
             dysfunction,hyperprolactinemia,diabetes)&#xD;
&#xD;
          -  Chronic diseases (renal insufficiency, cardiovascular, hepatic disease)&#xD;
&#xD;
          -  Oral contraceptive use, anti-androgenic,glucocorticoid, anti-hypertansive-&#xD;
             anti-diabetic drug use&#xD;
&#xD;
          -  Smoking or alcohol use&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilhan B Delibas, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gaziosmanpasa University Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Esra Laloglu, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Erzurum Halk Saglıgı Laboratuvarı</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gaziosmanpasa University</name>
      <address>
        <city>Tokat</city>
        <zip>60000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tokat Gaziosmanpasa University</investigator_affiliation>
    <investigator_full_name>İlhan Bahri Delibas</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>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/NCT03019679
org study id: GaziosmanpasaU
nct id: NCT03019679
lead sponsor: 
has dmc: Yes
In this study the investigators aimed to investigate whether there is a relation between
      polycystic ovary syndrome and serum endocan levels.
Polycystic ovary syndrome is a disorder which is associated with insulin resistance,
      diabetes, obesity, and cardiovascular disease. Endothelial dysfunction, which is known to be
      an early marker of atherosclerosis, has also been shown to have an association with poycystic
      ovary syndrome. In this study the investigators aimed to investigate whether there is a
      relation between polycystic ovary syndrome and serum endocan levels. For this purpose the
      investigators designed a prospective study including two groups. The diagnosis of polycystic
      ovary syndrome was made in the presence of ;oligo- and/or anovulation,clinical
      hyperandrogenism and polycystic ovaries. Clinical hyperandrogenism was defined by the
      presence of hirsutism , acne, or the presence of androgenic alopecia, body mass index (BMI)
      was calculated as weight in kilograms divided by the square of height in meters. The two
      groups are compared considering their serum endocan levels,follicle stimulating hormone
      (FSH), luteinizing hormone (LH), Dihydroepiandesterone sulphate (DHEAS), total testesterone
      (TT), estradiol (E2) and thyroid stimulating hormone (TSH), fasting blood glucose,
      triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein, and
      C-reactive protein (CRP) levels.
observational model: Case-Control
time perspective: Prospective
measure: Serum endocan level and its relationship with Polycystic Ovary Syndrome
time frame: 3 months
arm group label: Study group
description: Patients with polycystic ovary syndrome
arm group label: Control group
description: Patients without polycyctic ovary syndrome
serum samples,centrifuged
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ilhan B Delibas, M.D.
role: Principal Investigator
affiliation: Gaziosmanpasa University Department of Obstetrics and Gynecology
last name: Esra Laloglu, M.D.
role: Study Chair
affiliation: Erzurum Halk Saglıgı Laboratuvarı
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Tokat Gaziosmanpasa University
investigator full name: İlhan Bahri Delibas
investigator title: Assistant Professor
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome