<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/NCT02236962</url>
  </required_header>
  <id_info>
    <org_study_id>15-12</org_study_id>
    <nct_id>NCT02236962</nct_id>
  </id_info>
  <brief_title>Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment</brief_title>
  <official_title>Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayside Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baker Heart and Diabetes Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bayside Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity is epidemic in Australia, and current preventative strategies have had limited&#xD;
      success in alleviating this health crisis. While numerous options are available for treatment&#xD;
      of obesity, most do not result in sustained weight reduction. Obesity results from an&#xD;
      imbalance between energy intake and expenditure, therefore new methods that correct this&#xD;
      imbalance are essential for effective long-term treatment. Rodent studies show that brown&#xD;
      adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore&#xD;
      targeting BAT to increase its activity (energy burning rate) and quantity in humans is&#xD;
      potentially a powerful tool for the treatment of obesity and related diseases. BAT has only&#xD;
      recently been irrefutably identified in adult humans therefore little is known about how it&#xD;
      functions in humans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <primary_completion_date type="Anticipated">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>brown adipose tissue activity</measure>
    <time_frame>3 years</time_frame>
    <description>measured via PET-CT</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Obesity</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>lactose powder in equivalent capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sympathetic agonist and thiazolidinedione</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ephedrine, pioglitazone</intervention_name>
    <arm_group_label>Drug treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males aged 19 - 35 years&#xD;
&#xD;
          -  Free of overt coronary disease (on history, medical examination and ECG)&#xD;
&#xD;
          -  Unmedicated&#xD;
&#xD;
          -  No major illness&#xD;
&#xD;
          -  BMI &lt;27 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Participant in research projects involving ionising radiation within the past 5 years.&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Fasting plasma glucose &gt; 6.0 mmol/L&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Melissa F Formosa, B Sci</last_name>
    <phone>+61 9076 1652</phone>
    <email>m.formosa@alfred.org.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrew L Carey, PhD</last_name>
    <phone>+61 8532 1251</phone>
    <email>andrew.carey@bakeridi.edu.au</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa F Formosa, B Sci</last_name>
      <phone>+61 9076 6518</phone>
      <email>m.formosa@alfred.org.au</email>
    </contact>
    <investigator>
      <last_name>Bronwyn A Kingwell, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>January 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</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>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pioglitazone</mesh_term>
    <mesh_term>Ephedrine</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/NCT02236962
org study id: 15-12
nct id: NCT02236962
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Obesity is epidemic in Australia, and current preventative strategies have had limited
      success in alleviating this health crisis. While numerous options are available for treatment
      of obesity, most do not result in sustained weight reduction. Obesity results from an
      imbalance between energy intake and expenditure, therefore new methods that correct this
      imbalance are essential for effective long-term treatment. Rodent studies show that brown
      adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore
      targeting BAT to increase its activity (energy burning rate) and quantity in humans is
      potentially a powerful tool for the treatment of obesity and related diseases. BAT has only
      recently been irrefutably identified in adult humans therefore little is known about how it
      functions in humans.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: brown adipose tissue activity
time frame: 3 years
description: measured via PET-CT
arm group label: Placebo
arm group type: Placebo Comparator
description: lactose powder in equivalent capsule
arm group label: Drug treatment
arm group type: Experimental
description: sympathetic agonist and thiazolidinedione
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Ephedrine, pioglitazone
arm group label: Drug treatment
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melissa F Formosa, B Sci
phone: +61 9076 1652
email: m.formosa@alfred.org.au
last name: Andrew L Carey, PhD
phone: +61 8532 1251
email: andrew.carey@bakeridi.edu.au
facility: 
status: Recruiting
contact: 
investigator: 
country: Australia
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Pioglitazone
mesh term: Ephedrine