<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/NCT03029377</url>
  </required_header>
  <id_info>
    <org_study_id>161423</org_study_id>
    <nct_id>NCT03029377</nct_id>
  </id_info>
  <brief_title>Noradrenergic and Stress-Related Etiologies of Chronic Fatigue Syndrome</brief_title>
  <official_title>Noradrenergic and Stress-Related Etiologies of Chronic Fatigue Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      The objective of this study is to measure sympathetic nervous system function and stress&#xD;
      responses in patients with clinically documented and self-reported chronic fatigue that is&#xD;
      worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and&#xD;
      stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS)&#xD;
      and who self-identify with stress induced worsening fatigue, will be compared to data from&#xD;
      normal individuals pre and post-stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Symptoms of Chronic Fatigue Syndrome (CFS) are critically important to study as patients&#xD;
      report that these symptoms are often profoundly debilitating and an impediment to effective&#xD;
      daily functioning as well as effective vocational and social functioning, while also&#xD;
      contributing to a significantly increased risk of psychiatric illness and diminished quality&#xD;
      of life. Previous Phenome-Wide Association (PheWAS) studies revealed a link between a&#xD;
      norepinephrine transporter (NET) genetic variant and CFS. Based on the potential function of&#xD;
      the variant and published literature, elevated norepinephrine (NE) levels may underlie at&#xD;
      least some cluster of fatigue symptoms. Some patients may experience chronic fatigue that is&#xD;
      due to an excess of circulating NE, and fatigue symptoms are reported by our patient&#xD;
      population to be commonly exacerbated by stress. This study will test the hypothesis that in&#xD;
      a subset of people with severely debilitating fatigue of long duration (&gt;6 months) that is&#xD;
      worsened by stress identified through the Vanderbilt electronic health record phenotyping&#xD;
      study, have chronic over-release of the hormone NE into the bloodstream/periphery over time&#xD;
      that results in an overload of NE. This overload of NE causes a compensatory but deleterious&#xD;
      effect on the brain and nervous system, including sympathetic effects and dysregulated&#xD;
      physiologic response to stress. Thus, while numerous currently approved therapies that target&#xD;
      NET inhibit the transporter, a drug with the opposite mechanism of action, a NET activator&#xD;
      that would decrease circulating NE, may have efficacy in treating underlying pathophysiology&#xD;
      of chronic fatigue.&#xD;
&#xD;
      Baseline NE levels and stress-induced NE levels in patients who fulfill criteria for CFS and&#xD;
      who self-identify with stress induced worsening fatigue, will be compared to data from normal&#xD;
      individuals pre and post-stress. After all inclusion criteria has been confirmed, an IV will&#xD;
      be placed for blood collection, a continuous electrocardiographic trace and blood pressure&#xD;
      cuff will be placed on the subject's arm and finger. Subjects will undergo a posture study,&#xD;
      autonomic reflex testing, and Stroop stress testing each followed by blood specimen&#xD;
      collection. An optional blood draw for DNA analysis will occur after patients have been&#xD;
      provided lunch. Questionnaires will be completed after study procedures and patients have&#xD;
      been provided lunch. Study blood collection will total up to 28 milliliters (mL): 5 mL for&#xD;
      cytokines, 20 mL for catecholamines, and optional 3 mL for DNA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">February 23, 2018</completion_date>
  <primary_completion_date type="Actual">February 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>dihydroxyphenylglycol (DHPG)/norepinephrine (NE) Ratio (post stress)</measure>
    <time_frame>Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)</time_frame>
    <description>Change in DHPG/NE Ratio from Baseline to post stress compared across arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DHPG/NE Ratio (post Autonomic Function test)</measure>
    <time_frame>Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)</time_frame>
    <description>Change in DHPG/NE Ratio from Baseline to post Autonomic Function test compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DHPG/NE Ratio (post Standing position)</measure>
    <time_frame>Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)</time_frame>
    <description>Change in DHPG/NE Ratio from Baseline to post Standing position compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DHPG/NE Ratio (post Sitting position)</measure>
    <time_frame>Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)</time_frame>
    <description>Change in DHPG/NE Ratio from Baseline to post Sitting position compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute DHPG and NE Levels (post stress)</measure>
    <time_frame>Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)</time_frame>
    <description>Change in absolute DHPG and NE Levels from Baseline to post stress compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute DHPG and NE Levels (post Autonomic Function test)</measure>
    <time_frame>Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)</time_frame>
    <description>Change in DHPG and NE levels from Baseline to post Autonomic Function test compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute DHPG and NE Levels (post Standing position)</measure>
    <time_frame>Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)</time_frame>
    <description>Change in absolute DHPG and NE Levels from Baseline to post Standing position compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute DHPG and NE Levels (post Sitting position)</measure>
    <time_frame>Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)</time_frame>
    <description>Change in DHPG and NE levels from Baseline to post Sitting position compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue as assessed by Multidimensional Assessment of Fatigue Scale (MAF)</measure>
    <time_frame>End of Study Visit (approximately 140 minutes post-baseline blood collection)</time_frame>
    <description>Mean values +/- standard deviation (SD) compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood as assessed by Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>End of Study Visit (approximately 140 minutes post-baseline blood collection)</time_frame>
    <description>Mean values +/- SD compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as assessed by 36-Item Short Form Survey Instrument (SF-36)</measure>
    <time_frame>End of Study Visit (approximately 140 minutes post-baseline blood collection)</time_frame>
    <description>Mean values +/- SD compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress as assessed by Stress Overload Scale</measure>
    <time_frame>Beginning of Study Visit (Approximately 15 minutes pre-baseline blood collection)</time_frame>
    <description>Mean values +/- SD compared across arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines</measure>
    <time_frame>At baseline (approximately 30 minutes after supine position start)</time_frame>
    <description>Compared across arms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Chronic Fatigue Syndrome</condition>
  <arm_group>
    <arm_group_label>Chronic Fatigue Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients between 18-60 years of age with fatigue symptoms who meet preliminary chronic fatigue phenotype criteria and complete preliminary screening surveys. Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients between 18-60 years of age with no known conditions or prescription medications who meet preliminary screening criteria. Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Posture Study, Autonomic Function Tests, and a Stress Test</intervention_name>
    <description>Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function at baseline, in three postural positions, after autonomic tests, and after a stress test.</description>
    <arm_group_label>Chronic Fatigue Patients</arm_group_label>
    <arm_group_label>Healthy Controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Chronic Fatigue Participants:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed chronic fatigue with severity &gt;50 on a scale of 1 to 100 that is not&#xD;
             improving over time&#xD;
&#xD;
          -  Meet The Centers for Disease Control and Prevention (CDC) diagnostic criteria of CFS&#xD;
             (self-reported persistent or relapsing fatigue lasting 6 or more consecutive months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects &lt;18 or &gt;60 years&#xD;
&#xD;
          -  Obesity, defined as a BMI of 30 or more&#xD;
&#xD;
          -  Presence of other medical or psychiatric conditions known to cause fatigue&#xD;
             (alcohol/drug abuse, anorexia nervosa, bipolar disorder, bulimia nervosa, dementia,&#xD;
             major depression, psychotic/delusional disorders, schizophrenia)&#xD;
&#xD;
          -  Presence of sleep disorder/disruption known to cause fatigue (sleep apnea, narcolepsy)&#xD;
&#xD;
          -  Cardiovascular, pulmonary, hepatic, or hematological disease by history or prior&#xD;
             testing defined as significant by investigator (including but not limited to chronic&#xD;
             hepatitis, chronic kidney disease, cirrhosis, emphysema, heart failure, HIV, lupus,&#xD;
             multiple sclerosis, myasthenia gravis, rheumatoid arthritis)&#xD;
&#xD;
          -  History of hypertension defined as supine resting BP&gt;145/95 mmHg off medications or&#xD;
             needing antihypertensive medication&#xD;
&#xD;
          -  Patients taking medications that can affect autonomic function or plasma&#xD;
             catecholamines (vasoactive drugs), stimulants, and/or are sedatives&#xD;
&#xD;
          -  Other factors which in the opinion of the investigator could potentially impact the&#xD;
             study outcomes (e.g., underlying disease, medications, history)* or prevent the&#xD;
             participant from completing the protocol (poor compliance or unpredictable schedule)&#xD;
&#xD;
          -  Inability to stand unassisted for 10 minutes&#xD;
&#xD;
          -  Patients who are bedridden or chair-ridden&#xD;
&#xD;
          -  Patients who are colorblind&#xD;
&#xD;
          -  Inability or refusal to give informed consent for any reason including a diagnosis of&#xD;
             dementia or cognitive impairment&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#xD;
&#xD;
        Healthy Control Participants:&#xD;
&#xD;
          -  Participant with no significant reported conditions or medications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects &lt;18 or &gt;60 years&#xD;
&#xD;
          -  Obesity, defined as a BMI of 30 or more&#xD;
&#xD;
          -  Presence of any serious or chronic disease, or prescription medication as deemed by&#xD;
             investigator including hypertension as defined by supine resting BP &gt;145/95 mmHg off&#xD;
             medications or needing antihypertensive medication&#xD;
&#xD;
          -  Other factors which in the investigator's opinion would prevent the participant from&#xD;
             completing the protocol, including poor compliance during previous studies or an&#xD;
             unpredictable schedule&#xD;
&#xD;
          -  Inability to stand unassisted for 10 minutes&#xD;
&#xD;
          -  Patients who are bedridden or chair-ridden&#xD;
&#xD;
          -  Patients who are colorblind&#xD;
&#xD;
          -  Inability or refusal to give informed consent for any reason including a diagnosis of&#xD;
             dementia or cognitive impairment&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#xD;
&#xD;
          -  Stress Overload Score above 66&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gordon Bernard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cdc.gov/cfs/</url>
    <description>CDC - Chronic Fatigue Syndrome (CFS)</description>
  </link>
  <reference>
    <citation>Okamoto LE, Raj SR, Peltier A, Gamboa A, Shibao C, Diedrich A, Black BK, Robertson D, Biaggioni I. Neurohumoral and haemodynamic profile in postural tachycardia and chronic fatigue syndromes. Clin Sci (Lond). 2012 Feb;122(4):183-92. doi: 10.1042/CS20110200.</citation>
    <PMID>21906029</PMID>
  </reference>
  <reference>
    <citation>Shirey-Rice JK, Klar R, Fentress HM, Redmon SN, Sabb TR, Krueger JJ, Wallace NM, Appalsamy M, Finney C, Lonce S, Diedrich A, Hahn MK. Norepinephrine transporter variant A457P knock-in mice display key features of human postural orthostatic tachycardia syndrome. Dis Model Mech. 2013 Jul;6(4):1001-11. doi: 10.1242/dmm.012203. Epub 2013 Apr 4.</citation>
    <PMID>23580201</PMID>
  </reference>
  <reference>
    <citation>Danciu I, Cowan JD, Basford M, Wang X, Saip A, Osgood S, Shirey-Rice J, Kirby J, Harris PA. Secondary use of clinical data: the Vanderbilt approach. J Biomed Inform. 2014 Dec;52:28-35. doi: 10.1016/j.jbi.2014.02.003. Epub 2014 Feb 14.</citation>
    <PMID>24534443</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>April 25, 2018</last_update_submitted>
  <last_update_submitted_qc>April 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Gordon Bernard</investigator_full_name>
    <investigator_title>Executive Vice President for Research</investigator_title>
  </responsible_party>
  <keyword>CFS</keyword>
  <keyword>Stress</keyword>
  <keyword>Norepinephrine Transporter (NET)</keyword>
  <keyword>Norepinephrine (NE)</keyword>
  <keyword>Healthy Controls</keyword>
  <keyword>Fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_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/NCT03029377
org study id: 161423
nct id: NCT03029377
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to measure sympathetic nervous system function and stress
      responses in patients with clinically documented and self-reported chronic fatigue that is
      worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and
      stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS)
      and who self-identify with stress induced worsening fatigue, will be compared to data from
      normal individuals pre and post-stress.
Symptoms of Chronic Fatigue Syndrome (CFS) are critically important to study as patients
      report that these symptoms are often profoundly debilitating and an impediment to effective
      daily functioning as well as effective vocational and social functioning, while also
      contributing to a significantly increased risk of psychiatric illness and diminished quality
      of life. Previous Phenome-Wide Association (PheWAS) studies revealed a link between a
      norepinephrine transporter (NET) genetic variant and CFS. Based on the potential function of
      the variant and published literature, elevated norepinephrine (NE) levels may underlie at
      least some cluster of fatigue symptoms. Some patients may experience chronic fatigue that is
      due to an excess of circulating NE, and fatigue symptoms are reported by our patient
      population to be commonly exacerbated by stress. This study will test the hypothesis that in
      a subset of people with severely debilitating fatigue of long duration (>6 months) that is
      worsened by stress identified through the Vanderbilt electronic health record phenotyping
      study, have chronic over-release of the hormone NE into the bloodstream/periphery over time
      that results in an overload of NE. This overload of NE causes a compensatory but deleterious
      effect on the brain and nervous system, including sympathetic effects and dysregulated
      physiologic response to stress. Thus, while numerous currently approved therapies that target
      NET inhibit the transporter, a drug with the opposite mechanism of action, a NET activator
      that would decrease circulating NE, may have efficacy in treating underlying pathophysiology
      of chronic fatigue.

      Baseline NE levels and stress-induced NE levels in patients who fulfill criteria for CFS and
      who self-identify with stress induced worsening fatigue, will be compared to data from normal
      individuals pre and post-stress. After all inclusion criteria has been confirmed, an IV will
      be placed for blood collection, a continuous electrocardiographic trace and blood pressure
      cuff will be placed on the subject's arm and finger. Subjects will undergo a posture study,
      autonomic reflex testing, and Stroop stress testing each followed by blood specimen
      collection. An optional blood draw for DNA analysis will occur after patients have been
      provided lunch. Questionnaires will be completed after study procedures and patients have
      been provided lunch. Study blood collection will total up to 28 milliliters (mL): 5 mL for
      cytokines, 20 mL for catecholamines, and optional 3 mL for DNA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: dihydroxyphenylglycol (DHPG)/norepinephrine (NE) Ratio (post stress)
time frame: Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)
description: Change in DHPG/NE Ratio from Baseline to post stress compared across arms
measure: DHPG/NE Ratio (post Autonomic Function test)
time frame: Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)
description: Change in DHPG/NE Ratio from Baseline to post Autonomic Function test compared across arms
measure: DHPG/NE Ratio (post Standing position)
time frame: Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)
description: Change in DHPG/NE Ratio from Baseline to post Standing position compared across arms
measure: DHPG/NE Ratio (post Sitting position)
time frame: Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)
description: Change in DHPG/NE Ratio from Baseline to post Sitting position compared across arms
measure: Absolute DHPG and NE Levels (post stress)
time frame: Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)
description: Change in absolute DHPG and NE Levels from Baseline to post stress compared across arms
measure: Absolute DHPG and NE Levels (post Autonomic Function test)
time frame: Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)
description: Change in DHPG and NE levels from Baseline to post Autonomic Function test compared
measure: Absolute DHPG and NE Levels (post Standing position)
time frame: Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)
description: Change in absolute DHPG and NE Levels from Baseline to post Standing position compared across arms
measure: Absolute DHPG and NE Levels (post Sitting position)
time frame: Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)
description: Change in DHPG and NE levels from Baseline to post Sitting position compared across arms
measure: Fatigue as assessed by Multidimensional Assessment of Fatigue Scale (MAF)
time frame: End of Study Visit (approximately 140 minutes post-baseline blood collection)
description: Mean values +/- standard deviation (SD) compared across arms
measure: Mood as assessed by Hospital Anxiety and Depression Scale (HADS)
time frame: End of Study Visit (approximately 140 minutes post-baseline blood collection)
description: Mean values +/- SD compared across arms
measure: Quality of Life as assessed by 36-Item Short Form Survey Instrument (SF-36)
time frame: End of Study Visit (approximately 140 minutes post-baseline blood collection)
description: Mean values +/- SD compared across arms
measure: Stress as assessed by Stress Overload Scale
time frame: Beginning of Study Visit (Approximately 15 minutes pre-baseline blood collection)
description: Mean values +/- SD compared across arms
measure: Cytokines
time frame: At baseline (approximately 30 minutes after supine position start)
description: Compared across arms
arm group label: Chronic Fatigue Patients
arm group type: Experimental
description: Patients between 18-60 years of age with fatigue symptoms who meet preliminary chronic fatigue phenotype criteria and complete preliminary screening surveys. Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function.
arm group label: Healthy Controls
arm group type: Active Comparator
description: Patients between 18-60 years of age with no known conditions or prescription medications who meet preliminary screening criteria. Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function.
intervention type: Other
intervention name: Posture Study, Autonomic Function Tests, and a Stress Test
description: Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function at baseline, in three postural positions, after autonomic tests, and after a stress test.
arm group label: Chronic Fatigue Patients
arm group label: Healthy Controls
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gordon Bernard, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
url: http://www.cdc.gov/cfs/
description: CDC - Chronic Fatigue Syndrome (CFS)
citation: Okamoto LE, Raj SR, Peltier A, Gamboa A, Shibao C, Diedrich A, Black BK, Robertson D, Biaggioni I. Neurohumoral and haemodynamic profile in postural tachycardia and chronic fatigue syndromes. Clin Sci (Lond). 2012 Feb;122(4):183-92. doi: 10.1042/CS20110200.
PMID: 21906029
citation: Shirey-Rice JK, Klar R, Fentress HM, Redmon SN, Sabb TR, Krueger JJ, Wallace NM, Appalsamy M, Finney C, Lonce S, Diedrich A, Hahn MK. Norepinephrine transporter variant A457P knock-in mice display key features of human postural orthostatic tachycardia syndrome. Dis Model Mech. 2013 Jul;6(4):1001-11. doi: 10.1242/dmm.012203. Epub 2013 Apr 4.
PMID: 23580201
citation: Danciu I, Cowan JD, Basford M, Wang X, Saip A, Osgood S, Shirey-Rice J, Kirby J, Harris PA. Secondary use of clinical data: the Vanderbilt approach. J Biomed Inform. 2014 Dec;52:28-35. doi: 10.1016/j.jbi.2014.02.003. Epub 2014 Feb 14.
PMID: 24534443
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Gordon Bernard
investigator title: Executive Vice President for Research
mesh term: Fatigue Syndrome, Chronic
mesh term: Syndrome
mesh term: Fatigue
sharing ipd: No