<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/NCT02244567</url>
  </required_header>
  <id_info>
    <org_study_id>Beni-Suef 4</org_study_id>
    <nct_id>NCT02244567</nct_id>
  </id_info>
  <brief_title>Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women</brief_title>
  <acronym>U-C OC IN PCOS</acronym>
  <official_title>Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beni-Suef University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beni-Suef University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired&#xD;
      insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women&#xD;
      trying to interfere with the pathophysiology of PCOS in these women as followed up by serum&#xD;
      UC-OC levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Under-carboxylated osteocalcin (ucOC), the precursor substrate of bone biomarker OC is a&#xD;
      potent regulator of energy metabolism by promoting insulin production and adiponectin&#xD;
      synthesis and decreasing fat stores.UcOC has a potential role in the physiopathology of&#xD;
      polycystic ovary syndrome (PCOS), a common disorder defined by the constellation of&#xD;
      anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.Circulating&#xD;
      ucOC concentration is related to key endocrine PCOS characteristics in a weight-dependent&#xD;
      manner. Within the bone-pancreas loop, high ucOC may favor insulin release in lean&#xD;
      hyperandrogenic women to compensate for impaired insulin sensitivity.We will investigate&#xD;
      serum uc-OC responses to insulin sensitizing therapies in lean hyperandrogenic polycystic&#xD;
      ovary syndrome (PCOS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>High Serum under-carboxylated osteocalcin</measure>
    <time_frame>3 months</time_frame>
    <description>Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metformin therapy</measure>
    <time_frame>3 months</time_frame>
    <description>Cidophage 850 mg twice daily will be given for three months to pcos patients who are hyperandrogenic and lean then serum uc-oc will be measured after therapy.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Polycystic Ovarian Syndrome</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serum under-carboxylated osteocalcin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Serum uc-oc will be measured before and after 3 months of treatment with cidophage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Other group of patients with high serum UC-OC will be given a placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 850 mg twice daily for 3 months</intervention_name>
    <description>This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.</description>
    <arm_group_label>Metformin</arm_group_label>
    <other_name>Cidophage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Serum uc-oc</intervention_name>
    <description>Serum uc-oc is a bone biomarker involved in incraesing insulin in pathophysiology of PCOS. It will be measured in serum of pcos patients before and after treatment with metformin for 3 months.</description>
    <arm_group_label>Serum under-carboxylated osteocalcin</arm_group_label>
    <other_name>Serum undercarboxylated-osteocalcin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>drug</intervention_name>
    <description>This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>vitamin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lean women BMI 25 or less&#xD;
&#xD;
          -  Hyperandrogenic clinically and/or biochemically.&#xD;
&#xD;
          -  Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI more than 20&#xD;
&#xD;
          -  Other causes of hyperandrogenism&#xD;
&#xD;
          -  Other causes of metabolic disorders or diabetes.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nesreen A Shehata, MD</last_name>
    <phone>00201227866337</phone>
    <email>nesoomar@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Abdelgany M Hassan, MD</last_name>
    <phone>00201017801604</phone>
    <email>abdelgany2@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nesreen Abdel Fattah Abdullah Shehata</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nesreen A Shehata, MD</last_name>
      <phone>00201227866337</phone>
      <email>nesoomar@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/</url>
    <description>Pepene CE. Serum under-carboxylated osteocalcin levels in women with polycystic ovary syndrome: weight-dependent relationships with endocrine and metabolic traits. J Ovarian Res. 2013;6(1):4.</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>January 30, 2021</last_update_submitted>
  <last_update_submitted_qc>January 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>Nesreen Abdel Fattah Abdullah Shehata</investigator_full_name>
    <investigator_title>Lecturer of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_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/NCT02244567
org study id: Beni-Suef 4
nct id: NCT02244567
lead sponsor: 
collaborator: 
has dmc: Yes
High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired
      insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women
      trying to interfere with the pathophysiology of PCOS in these women as followed up by serum
      UC-OC levels.
Under-carboxylated osteocalcin (ucOC), the precursor substrate of bone biomarker OC is a
      potent regulator of energy metabolism by promoting insulin production and adiponectin
      synthesis and decreasing fat stores.UcOC has a potential role in the physiopathology of
      polycystic ovary syndrome (PCOS), a common disorder defined by the constellation of
      anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.Circulating
      ucOC concentration is related to key endocrine PCOS characteristics in a weight-dependent
      manner. Within the bone-pancreas loop, high ucOC may favor insulin release in lean
      hyperandrogenic women to compensate for impaired insulin sensitivity.We will investigate
      serum uc-OC responses to insulin sensitizing therapies in lean hyperandrogenic polycystic
      ovary syndrome (PCOS).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: High Serum under-carboxylated osteocalcin
time frame: 3 months
description: Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.
measure: Metformin therapy
time frame: 3 months
description: Cidophage 850 mg twice daily will be given for three months to pcos patients who are hyperandrogenic and lean then serum uc-oc will be measured after therapy.
arm group label: Metformin
arm group type: Active Comparator
description: Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS.
arm group label: Serum under-carboxylated osteocalcin
arm group type: Active Comparator
description: Serum uc-oc will be measured before and after 3 months of treatment with cidophage.
arm group label: Placebo
arm group type: Active Comparator
description: Other group of patients with high serum UC-OC will be given a placebo.
intervention type: Drug
intervention name: Metformin 850 mg twice daily for 3 months
description: This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.
arm group label: Metformin
other name: Cidophage
intervention type: Procedure
intervention name: Serum uc-oc
description: Serum uc-oc is a bone biomarker involved in incraesing insulin in pathophysiology of PCOS. It will be measured in serum of pcos patients before and after treatment with metformin for 3 months.
arm group label: Serum under-carboxylated osteocalcin
other name: Serum undercarboxylated-osteocalcin
intervention type: Other
intervention name: drug
description: This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.
arm group label: Placebo
other name: vitamin
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: No
last name: Nesreen A Shehata, MD
phone: 00201227866337
email: nesoomar@yahoo.com
last name: Abdelgany M Hassan, MD
phone: 00201017801604
email: abdelgany2@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
url: http://www.ncbi.nlm.nih.gov/
description: Pepene CE. Serum under-carboxylated osteocalcin levels in women with polycystic ovary syndrome: weight-dependent relationships with endocrine and metabolic traits. J Ovarian Res. 2013;6(1):4.
responsible party type: Principal Investigator
investigator affiliation: Beni-Suef University
investigator full name: Nesreen Abdel Fattah Abdullah Shehata
investigator title: Lecturer of Obstetrics and Gynecology
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Metformin