<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/NCT04448730</url>
  </required_header>
  <id_info>
    <org_study_id>EZTB24</org_study_id>
    <nct_id>NCT04448730</nct_id>
  </id_info>
  <brief_title>Polycystic Ovary Syndrome and BETATROPHIN</brief_title>
  <official_title>Can the Betatrophin be a Reliable Marker of Insulin Resistance in Normal Weight and Overweight Women With Polycystic Ovary Syndrome?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hatice Akkaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kayseri Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 is an original study giving an information about the association body mass index,&#xD;
      polycystic ovary syndrome and betatrophin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Betatrophin is a protein hormone which has a significant role in glucose&#xD;
      homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum&#xD;
      betatrophin in overweight and normal weight women with PCOS.&#xD;
&#xD;
      Material and Method: Thirty-five patients normal weight women with PCOS (BMI&lt;25) and 38 obese&#xD;
      women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients&#xD;
      were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA&#xD;
      method and then compared between these two groups besides the following additional parameters&#xD;
      as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral&#xD;
      glucose tolerance test) results and HOMA-IR levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>serum Betatrophin levels</measure>
    <time_frame>30 min</time_frame>
    <description>ng/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waist/hip ratio</measure>
    <time_frame>5 min</time_frame>
    <description>centimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>75 gr OGTT(oral glucose tolerance test)</measure>
    <time_frame>2 hours</time_frame>
    <description>(mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI (body mass index)</measure>
    <time_frame>5 minute</time_frame>
    <description>kg/m2</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">73</enrollment>
  <condition>Polycystic Ovary</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Group 1 (normal weight with PCOS )</arm_group_label>
    <description>35 cases</description>
  </arm_group>
  <arm_group>
    <arm_group_label>overweight PCOS</arm_group_label>
    <description>38 cases</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum marker levels</intervention_name>
    <description>two groups comparisons</description>
    <arm_group_label>Group 1 (normal weight with PCOS )</arm_group_label>
    <arm_group_label>overweight PCOS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Comparison of the Betatrohin serum marker of insulin resistance in normal weight and&#xD;
        overweight women with polycystic ovary syndrome cases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Polycystic ovary syndrome according to 2003 Rotterdam PCOS Consensus diagnostic criteria&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  an additional systemic disease (i.e.,hyperprolactinemia, thyroid dysfunction, liver or&#xD;
             kidney diseases, cardiovascular disease, hyperlipidemia, type 1 or type 2 diabetes,&#xD;
             chronic or acute infection within the previous 30 days),&#xD;
&#xD;
          -  morbid obesity,&#xD;
&#xD;
          -  smoking,&#xD;
&#xD;
          -  the use of medications for contraception, androgen excess, hypertension, hyperglycemia&#xD;
             or dyslipidemia at least 3 months before the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kayseri Doğumevi</name>
      <address>
        <city>Kocasinan</city>
        <state>Kayseri</state>
        <zip>38090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kayseri Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Hatice Akkaya</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>Betatrophin</keyword>
  <keyword>PCOS</keyword>
  <keyword>obesity</keyword>
  <keyword>insulin resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>If needed</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>1 year</ipd_time_frame>
    <ipd_access_criteria>journals editors request</ipd_access_criteria>
  </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/NCT04448730
org study id: EZTB24
nct id: NCT04448730
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an original study giving an information about the association body mass index,
      polycystic ovary syndrome and betatrophin.
Introduction: Betatrophin is a protein hormone which has a significant role in glucose
      homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum
      betatrophin in overweight and normal weight women with PCOS.

      Material and Method: Thirty-five patients normal weight women with PCOS (BMI<25) and 38 obese
      women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients
      were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA
      method and then compared between these two groups besides the following additional parameters
      as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral
      glucose tolerance test) results and HOMA-IR levels.
observational model: Cohort
time perspective: Cross-Sectional
measure: serum Betatrophin levels
time frame: 30 min
description: ng/L
measure: Waist/hip ratio
time frame: 5 min
description: centimeter
measure: 75 gr OGTT(oral glucose tolerance test)
time frame: 2 hours
description: (mg/dl)
measure: BMI (body mass index)
time frame: 5 minute
description: kg/m2
arm group label: Group 1 (normal weight with PCOS )
description: 35 cases
arm group label: overweight PCOS
description: 38 cases
intervention type: Diagnostic Test
intervention name: serum marker levels
description: two groups comparisons
arm group label: Group 1 (normal weight with PCOS )
arm group label: overweight PCOS
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Hatice Akkaya
investigator title: associate professor
mesh term: Polycystic Ovary Syndrome
sharing ipd: Yes
ipd description: If needed
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 1 year
ipd access criteria: journals editors request