<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/NCT01665716</url>
  </required_header>
  <id_info>
    <org_study_id>NL32242.041.10</org_study_id>
    <secondary_id>10-345</secondary_id>
    <nct_id>NCT01665716</nct_id>
  </id_info>
  <brief_title>Ovarian Ageing in Type 1 Diabetes Mellitus</brief_title>
  <acronym>OVADIA</acronym>
  <official_title>Ovarian Ageing in Type 1 Diabetes Mellitus: the Role of Vascular Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In healthy women, early menopause is an event that is associated with the exacerbation of&#xD;
      several risk factors of cardiovascular and skeletal disease. The occurrence of an early&#xD;
      menopause may have even greater impact in women with type 1 diabetes mellitus (DM-1). A small&#xD;
      number of studies has demonstrated that DM-1 patients experience cycle irregularity and&#xD;
      menopause at a younger age compared to controls. In addition, initial studies have suggested&#xD;
      that also in regular cycling DM-1 women a decreased ovarian reserve status for age is&#xD;
      present. The explanation for this early decay in ovarian reserve in DM-1 patients remains&#xD;
      unknown. Next to auto immunity, vascular factors may be possible contributors to accelerated&#xD;
      ovarian ageing in DM-1 patients.&#xD;
&#xD;
      Confirmation of more accelerated ovarian ageing in DM-1 women is urgently needed in view of&#xD;
      the added risk factors outlined above. Also, the mechanisms behind the advanced ovarian&#xD;
      ageing, with focus on vascular factors, may shed new light on our understanding of the&#xD;
      ovarian ageing process per se.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>OVADIA 1: serum AMH level</measure>
    <time_frame>Blood withdrawel once at screening</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>OVADIA 2: Age at menopause</measure>
    <time_frame>Assesed once in questionnaire</time_frame>
  </primary_outcome>
  <enrollment type="Actual">290</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Part I: Premenopausal women diagnosed with DM-1 older than 18 years and registered at the&#xD;
        department for Endocrinology of in several Dutch hospitals.&#xD;
&#xD;
        Reference group: the Scheffer, Van Rooij, De Vet (SRV) cohort of normal fertile Caucasian&#xD;
        women (n=250), recruited in the period of 1990 till 2000.&#xD;
&#xD;
        For the substudy concerning EPCs will we recruite a control group of 20 healthy female&#xD;
        age-matched controls. We will recruite these women within the UMC Utrecht due to logistic&#xD;
        reasons.&#xD;
&#xD;
        Part II: Postmenopausal women diagnosed with DM-1 and registered at the department for&#xD;
        Endocrinology of several Dutch hospitals. Reference group:a selection of women from the&#xD;
        Prospect-EPIC cohort, who had experienced natural menopause&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients: females diagnosed with type 1 diabetes mellitus&#xD;
&#xD;
          -  Controls: healthy age-matched female controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Induced menopause: surgical (premenopausal hysterectomy and/or bilateral ovariectomy),&#xD;
             chemo- or radiation therapy, ovarian surgery and irregular menstrual cycles.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Broekmans, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3508 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>April 10, 2014</last_update_submitted>
  <last_update_submitted_qc>April 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>Frank JM Broekmans</investigator_full_name>
    <investigator_title>Prof. Dr. F. J. M. Broekmans</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT01665716
org study id: NL32242.041.10
secondary id: 10-345
nct id: NCT01665716
lead sponsor: 
has dmc: No
In healthy women, early menopause is an event that is associated with the exacerbation of
      several risk factors of cardiovascular and skeletal disease. The occurrence of an early
      menopause may have even greater impact in women with type 1 diabetes mellitus (DM-1). A small
      number of studies has demonstrated that DM-1 patients experience cycle irregularity and
      menopause at a younger age compared to controls. In addition, initial studies have suggested
      that also in regular cycling DM-1 women a decreased ovarian reserve status for age is
      present. The explanation for this early decay in ovarian reserve in DM-1 patients remains
      unknown. Next to auto immunity, vascular factors may be possible contributors to accelerated
      ovarian ageing in DM-1 patients.

      Confirmation of more accelerated ovarian ageing in DM-1 women is urgently needed in view of
      the added risk factors outlined above. Also, the mechanisms behind the advanced ovarian
      ageing, with focus on vascular factors, may shed new light on our understanding of the
      ovarian ageing process per se.
observational model: Case-Control
time perspective: Cross-Sectional
measure: OVADIA 1: serum AMH level
time frame: Blood withdrawel once at screening
measure: OVADIA 2: Age at menopause
time frame: Assesed once in questionnaire
serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frank Broekmans, MD, PhD
role: Principal Investigator
affiliation: UMC Utrecht
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: Frank JM Broekmans
investigator title: Prof. Dr. F. J. M. Broekmans
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1