<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/NCT04482374</url>
  </required_header>
  <id_info>
    <org_study_id>19-2109</org_study_id>
    <nct_id>NCT04482374</nct_id>
  </id_info>
  <brief_title>Puberty Suppression and Cardiometabolic Health</brief_title>
  <official_title>Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</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 observational study will evaluate the effect of puberty suppression on insulin&#xD;
      sensitivity, metabolic rate and vascular health among transgender female youth at baseline&#xD;
      and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched&#xD;
      cisgender male controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in insulin sensitivity</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Insulin sensitivity assessed by the oral minimal model</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body composition (fat mass, fat-free mass)</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Body composition measured by DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting metabolic rate</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Resting metabolic rate assessed by indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in endothelial function</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Endothelial function assessed by brachial artery flow mediated dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in large elastic artery stiffness</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Large elastic assessed by carotid ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cerebrovascular function</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Middle cerebral artery blood flow assessed using bilateral transcranial Doppler</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Transgenderism</condition>
  <condition>Insulin Sensitivity/Resistance</condition>
  <condition>Endothelial Dysfunction</condition>
  <condition>Vascular Stiffness</condition>
  <arm_group>
    <arm_group_label>Transgender females</arm_group_label>
    <description>Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cisgender males</arm_group_label>
    <description>Cisgender male controls</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        15 transgender females (male sex assigned at birth, female gender identity) and 15&#xD;
        cisgender males&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Identify as a transgender female or cisgender male&#xD;
&#xD;
          -  Age 9-14 years at the time of enrollment&#xD;
&#xD;
          -  Tanner Stage 2-3 baseline pubertal development&#xD;
&#xD;
          -  Plan to start gonadotropin releasing hormone analogue clinically in &lt; 2 months (for&#xD;
             transgender females only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the&#xD;
             study procedures&#xD;
&#xD;
          -  Type 1 or 2 diabetes (by medical history)&#xD;
&#xD;
          -  On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)&#xD;
&#xD;
          -  Hypertension (resting BP ≥ 140/90 mm/Hg)&#xD;
&#xD;
          -  Weight &gt; 400 lbs&#xD;
&#xD;
          -  On estrogen- or progesterone-containing medications at baseline&#xD;
&#xD;
          -  &gt;3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Transgender females, cisgender males</gender_description>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Natalie J Nokoff, MD, MSCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalie J Nokoff, MD, MSCS</last_name>
    <phone>720-777-6128</phone>
    <email>natalie.nokoff@childrenscolorado.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Nokoff, MD, MSCS</last_name>
      <phone>720-777-3607</phone>
      <email>Natalie.Nokoff@childrenscolorado.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04482374
org study id: 19-2109
nct id: NCT04482374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study will evaluate the effect of puberty suppression on insulin
      sensitivity, metabolic rate and vascular health among transgender female youth at baseline
      and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched
      cisgender male controls.
observational model: Cohort
time perspective: Prospective
measure: Change in insulin sensitivity
time frame: Baseline, 6 months
description: Insulin sensitivity assessed by the oral minimal model
measure: Change in body composition (fat mass, fat-free mass)
time frame: Baseline, 6 months
description: Body composition measured by DXA
measure: Change in resting metabolic rate
time frame: Baseline, 6 months
description: Resting metabolic rate assessed by indirect calorimetry
measure: Change in endothelial function
time frame: Baseline, 6 months
description: Endothelial function assessed by brachial artery flow mediated dilation
measure: Change in large elastic artery stiffness
time frame: Baseline, 6 months
description: Large elastic assessed by carotid ultrasound
measure: Change in cerebrovascular function
time frame: Baseline, 6 months
description: Middle cerebral artery blood flow assessed using bilateral transcranial Doppler
arm group label: Transgender females
description: Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months
arm group label: Cisgender males
description: Cisgender male controls
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Transgender females, cisgender males
minimum age: 9 Years
maximum age: 14 Years
last name: Natalie J Nokoff, MD, MSCS
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Natalie J Nokoff, MD, MSCS
phone: 720-777-6128
email: natalie.nokoff@childrenscolorado.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Insulin Resistance
mesh term: Hypersensitivity
sharing ipd: Undecided