<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/NCT03289559</url>
  </required_header>
  <id_info>
    <org_study_id>06-0010</org_study_id>
    <nct_id>NCT03289559</nct_id>
  </id_info>
  <brief_title>Effects of Testosterone and Fat Utilization</brief_title>
  <official_title>Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization</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>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>
      Evidence is accumulating that there are sex differences in energy and substrate metabolism.&#xD;
      The positive or negative consequences of such metabolic differences between men and women&#xD;
      need to be evaluated with respect to health outcomes. The importance of aberrant lipid&#xD;
      metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes&#xD;
      understanding the distinction between &quot;normal&quot; vs aberrant critical to future treatment and&#xD;
      prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism&#xD;
      and substrate oxidation in non-obese, healthy individuals, have been consistently observed.&#xD;
      In addition, distinct differences in men and women exist in the distribution of body fat,&#xD;
      with men typically having greater central adiposity than women. Accumulation of fat in the&#xD;
      abdomen is associated with an increased risk for metabolic abnormalities such as&#xD;
      hyperlipidemia and insulin resistance. In the current study, therefore, the role of&#xD;
      testosterone in determining the sex differences in catecholamine mediated substrate&#xD;
      metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots&#xD;
      will be addressed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2006</start_date>
  <completion_date type="Actual">January 1, 2014</completion_date>
  <primary_completion_date type="Actual">January 1, 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary fat tracer for storage of meal derived fatty acids</measure>
    <time_frame>4 weeks</time_frame>
    <description>50 uCi of [1-14C] oleic acid administered with an inpatient test meal</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Healthy</condition>
  <condition>Volunteers</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GnRH antagonist + Placebo Gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GnRH antagonist + Testosterone Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GnRH antagonist</intervention_name>
    <arm_group_label>GnRH antagonist + Placebo Gel</arm_group_label>
    <arm_group_label>GnRH antagonist + Testosterone Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aromatase Inhibitors</intervention_name>
    <arm_group_label>GnRH antagonist + Placebo Gel</arm_group_label>
    <arm_group_label>GnRH antagonist + Testosterone Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone gel</intervention_name>
    <arm_group_label>GnRH antagonist + Testosterone Gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  normal weight (BMI of 23-29.9 kg/m2)&#xD;
&#xD;
          -  not be highly trained (&lt; 5hrs of moderate intensity, planned exercise per week).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded if they have one or more of the following out-of-range&#xD;
             values measured on a fasting blood sample:&#xD;
&#xD;
          -  glucose &lt;65 or &gt; 110 mg/dl,&#xD;
&#xD;
          -  insulin &gt; 20 uU/ml,&#xD;
&#xD;
          -  thyroid stimulating hormone &lt;0.5 or &gt;5.0 uU/ml,&#xD;
&#xD;
          -  growth hormone &gt;2.5 ng/ml.&#xD;
&#xD;
          -  Subjects who may be:&#xD;
&#xD;
          -  anemic (hemoglobin &lt; 14.5 g/dl men ),&#xD;
&#xD;
          -  have abnormal liver function tests:&#xD;
&#xD;
               -  alanine amino transferase &gt; 47 U/l,&#xD;
&#xD;
               -  aspartate aminotransferase, &gt; 47 U/l,&#xD;
&#xD;
               -  alkaline phosphatase &lt;39 or &gt;117 U/l) or&#xD;
&#xD;
               -  creatinine (&lt;0.6 or &gt;1.1 mg/dl).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Bessesen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Aromatase Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03289559
org study id: 06-0010
nct id: NCT03289559
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evidence is accumulating that there are sex differences in energy and substrate metabolism.
      The positive or negative consequences of such metabolic differences between men and women
      need to be evaluated with respect to health outcomes. The importance of aberrant lipid
      metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes
      understanding the distinction between "normal" vs aberrant critical to future treatment and
      prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism
      and substrate oxidation in non-obese, healthy individuals, have been consistently observed.
      In addition, distinct differences in men and women exist in the distribution of body fat,
      with men typically having greater central adiposity than women. Accumulation of fat in the
      abdomen is associated with an increased risk for metabolic abnormalities such as
      hyperlipidemia and insulin resistance. In the current study, therefore, the role of
      testosterone in determining the sex differences in catecholamine mediated substrate
      metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots
      will be addressed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Dietary fat tracer for storage of meal derived fatty acids
time frame: 4 weeks
description: 50 uCi of [1-14C] oleic acid administered with an inpatient test meal
arm group label: Control
arm group type: No Intervention
arm group label: GnRH antagonist + Placebo Gel
arm group type: Placebo Comparator
arm group label: GnRH antagonist + Testosterone Gel
arm group type: Active Comparator
intervention type: Drug
intervention name: GnRH antagonist
arm group label: GnRH antagonist + Placebo Gel
arm group label: GnRH antagonist + Testosterone Gel
intervention type: Drug
intervention name: Aromatase Inhibitors
arm group label: GnRH antagonist + Placebo Gel
arm group label: GnRH antagonist + Testosterone Gel
intervention type: Drug
intervention name: Testosterone gel
arm group label: GnRH antagonist + Testosterone Gel
criteria: 
gender: All
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Bessesen, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
responsible party type: Sponsor
mesh term: Testosterone
mesh term: Aromatase Inhibitors
sharing ipd: No