<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/NCT01719484</url>
  </required_header>
  <id_info>
    <org_study_id>0805003899</org_study_id>
    <nct_id>NCT01719484</nct_id>
  </id_info>
  <brief_title>Functional MRI of Stress in Obesity</brief_title>
  <official_title>Functional Magnetic Resonance Imaging of Stress in Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the influence of obesity on brain activation during food cue, stress, and neutral&#xD;
      relaxing conditions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will participate in an fMRI session to examine changes in frontal and limbic brain&#xD;
      regions with food cues, stress and neutral/relaxing imagery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>No outcome measures for this study, this is an imaging study only</measure>
    <time_frame>Upon study completion</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Subjects deemed to be medically healthy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese</arm_group_label>
    <description>Subjects deemed to be medically obese</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        30 obese subjects and 30 matched healthy controls will be recruited for this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between ages 18-50 years old.&#xD;
&#xD;
          2. Able to read and write.&#xD;
&#xD;
          3. negative urine toxicology screens during intake appointments indicating no history of&#xD;
             current or past dependence on alcohol or illicit drug use.&#xD;
&#xD;
          4. WOMEN: have a regular menstrual cycle.&#xD;
&#xD;
          5. BMI: 30 &lt; BMI &lt; 35 for obese subjects (upper limit of 35 selected given our experience&#xD;
             with heavier individuals fitting comfortably in the fMRI scanner) and 18.5 &lt; BMI &lt;25&#xD;
             for normal weight subjects (Institute, 2006)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. any major neurological illness or injury and any current or prior clinically&#xD;
             significant mental health (including PTSD) or substance use disorder (with exception&#xD;
             of nicotine dependence) as determined by SCID interview;&#xD;
&#xD;
          2. Regular use of any psychoactive drugs including anxiolytics and antidepressants.&#xD;
&#xD;
          3. Any significant current medical condition such as neurological, cardiovascular,&#xD;
             endocrine, renal, liver, thyroid pathology; subjects on medications for any medical&#xD;
             condition will be excluded.&#xD;
&#xD;
          4. Any subjects with foreign ferromagnetic metal objects in their body or other MR&#xD;
             contraindications will be excluded including subjects who work as welders.&#xD;
&#xD;
          5. Women on oral contraceptives, peri- and post-menopausal women, and pregnant or&#xD;
             lactating women (as alterations in stress response are associated with these states).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc N Potenza, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>July 11, 2022</last_update_submitted>
  <last_update_submitted_qc>July 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</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>Obesity</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/NCT01719484
org study id: 0805003899
nct id: NCT01719484
lead sponsor: 
has dmc: Yes
To examine the influence of obesity on brain activation during food cue, stress, and neutral
      relaxing conditions
Subjects will participate in an fMRI session to examine changes in frontal and limbic brain
      regions with food cues, stress and neutral/relaxing imagery
observational model: Case-Control
time perspective: Prospective
measure: No outcome measures for this study, this is an imaging study only
time frame: Upon study completion
arm group label: Healthy
description: Subjects deemed to be medically healthy
arm group label: Obese
description: Subjects deemed to be medically obese
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marc N Potenza, MD, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity