<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/NCT01720862</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00051683</org_study_id>
    <nct_id>NCT01720862</nct_id>
  </id_info>
  <brief_title>Migraine and Body Composition</brief_title>
  <official_title>Migraine and Body Composition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to look at the association between migraine and obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research into the role of inflammatory markers and other obesity related proteins and&#xD;
      chemicals may help us understand migraine and lead to new treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>association between migraine and obesity - evaluate serum adipokine levels</measure>
    <time_frame>5 years</time_frame>
    <description>The first aim of the proposed research is to evaluate serum adipokine levels in a clinical cohort of obese and non-obese episodic and chronic migraineurs and examine their utility as markers of the presence or absence of migraine and their relationship to headache frequency.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT)</measure>
    <time_frame>five years</time_frame>
    <description>The second aim of the proposed research is to evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT),in the same clinical cohort of migraineurs to determine if regional adipose tissue differences exist between: (1) episodic migraineurs, (2) chronic migraineurs and (3) controls, thus contributing to the migraine-obesity relationship.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Migraine With and Without Aura</condition>
  <condition>Chronic Migraine</condition>
  <condition>Healthy Controls</condition>
  <arm_group>
    <arm_group_label>Episodic migraineurs</arm_group_label>
    <description>Those with migraines &gt;2 and &lt; 12 times per month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic migraineurs</arm_group_label>
    <description>Those with migraines greater than 14 days per month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Those without headaches other than occasional hangover, cold, flu headaches.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Premenopausal Caucasian women ages 18-55 years with or without migraine.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal women (18-55 years)&#xD;
&#xD;
          -  Normal weight (BMI = 18.5 - 24.9) or obese (BMI ≥ 30)&#xD;
&#xD;
          -  Diagnosis of episodic or chronic migraine or pain free control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of pain disorder other than migraine (e.g. irritable bowel syndrome)&#xD;
&#xD;
          -  Chronic conditions known to alter risk or pattern of migraine (e.g. hypothyroidism)&#xD;
&#xD;
          -  Illnesses that may affect adipokine levels (e.g. diabetes)&#xD;
&#xD;
          -  Clinically relevant abnormal glucose/cholesterol levels&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Potential participants who are unable to undergo MRI based on standard screening&#xD;
             questionnaire (those with brain aneurysm or surgical clips, certain types of&#xD;
             artificial heart valves, heart defibrillator or pacemaker, cochlear implants, eye&#xD;
             implants, blood vessel coil, recently placed artificial joints, certain types of&#xD;
             vascular stents, history of bullets, pellets, BBs, history of any implanted metal or&#xD;
             device or who have worked with sheet metal in the past)&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Barbara L Peterlin, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Johns Hopkins Bayview Headache Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>January 27, 2016</last_update_submitted>
  <last_update_submitted_qc>January 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Drs Barbara Peterlin</investigator_full_name>
    <investigator_title>Director of Headache Research, Johns Hopkins Bayview</investigator_title>
  </responsible_party>
  <keyword>migraine</keyword>
  <keyword>episodic migraine</keyword>
  <keyword>chronic migraine</keyword>
  <keyword>obesity</keyword>
  <keyword>non-obese</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</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/NCT01720862
org study id: NA_00051683
nct id: NCT01720862
lead sponsor: 
has dmc: No
This research is being done to look at the association between migraine and obesity.
Research into the role of inflammatory markers and other obesity related proteins and
      chemicals may help us understand migraine and lead to new treatment.
observational model: Case-Control
time perspective: Cross-Sectional
measure: association between migraine and obesity - evaluate serum adipokine levels
time frame: 5 years
description: The first aim of the proposed research is to evaluate serum adipokine levels in a clinical cohort of obese and non-obese episodic and chronic migraineurs and examine their utility as markers of the presence or absence of migraine and their relationship to headache frequency.
measure: association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT)
time frame: five years
description: The second aim of the proposed research is to evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT),in the same clinical cohort of migraineurs to determine if regional adipose tissue differences exist between: (1) episodic migraineurs, (2) chronic migraineurs and (3) controls, thus contributing to the migraine-obesity relationship.
arm group label: Episodic migraineurs
description: Those with migraines >2 and < 12 times per month.
arm group label: Chronic migraineurs
description: Those with migraines greater than 14 days per month.
arm group label: Controls
description: Those without headaches other than occasional hangover, cold, flu headaches.
serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara L Peterlin, DO
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Drs Barbara Peterlin
investigator title: Director of Headache Research, Johns Hopkins Bayview
mesh term: Migraine Disorders