<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/NCT02988687</url>
  </required_header>
  <id_info>
    <org_study_id>00930</org_study_id>
    <nct_id>NCT02988687</nct_id>
  </id_info>
  <brief_title>Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD</brief_title>
  <official_title>Metabolic and Quality of Life Effects of Growth Hormone Treatment in Patients With Traumatic Brain Injury and AGHD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Garcia, Jose M., MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Garcia, Jose M., MD, PhD</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This PILOT, NON-INTERVENTIONAL STUDY will follow patients about to start rhGH for a period of&#xD;
      six months and collect valuable pilot data to evaluate feasibility of a larger study and&#xD;
      treatment tolerability and compliance. The effect of rhGH on cognitive function, depression,&#xD;
      fatigue, sleep quality, and QOL will also be collected. This exploratory study will also&#xD;
      provide important information about recruitment and AGHD screening procedures in military&#xD;
      settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Growth hormone replacement has consistently shown improvements in body composition, exercise&#xD;
      capacity, endothelial function, inflammatory biomarkers, bone mineral density, lipoprotein&#xD;
      metabolism, and self-reported quality of Life (QOL) in patients suffering from adult growth&#xD;
      hormone deficiency (AGHD). One of the causes for AGHD is traumatic brain injury (TBI), a&#xD;
      condition that affects approximately 20% of Veterans from Operation Enduring Freedom (OEF),&#xD;
      Operation Iraqi Freedom (OIF), and Operation New Dawn (OND). Because OIF/OEF/OND Veterans are&#xD;
      a new population, there is a paucity of data regarding the effects of rhGH in these patients.&#xD;
      The investigators propose to perform a pilot observational study of Veterans with confirmed&#xD;
      adult growth hormone deficiency (AGHD) due to TBI who have been prescribed recombinant human&#xD;
      growth hormone (rhGH) replacement in order to determine changes in metabolic parameters and&#xD;
      QOL induced by rhGH.&#xD;
&#xD;
      Our hypothesis is that GH replacement will improve QOL and metabolic parameters (glucose,&#xD;
      insulin resistance, lipids, inflammatory markers, and body composition) in patients with&#xD;
      confirmed AGHD due to TBI.The primary aim for this proposal is to determine the effects of&#xD;
      rhGH treatment given daily for 6 months to Veterans with TBI and AGHD on QoL measured by the&#xD;
      Quality of Life Assessment for GHD in Adults questionnaire (QoL-AGHDA, primary outcome).&#xD;
      Secondary specific aims for this proposal are to gather high quality pilot data of the&#xD;
      effects of 6 months of rhGH replacement in Veterans with TBI and AGHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">October 2022</completion_date>
  <primary_completion_date type="Actual">October 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>AGHDA change</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>Quality of Life Assessment for GHD in Adults questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AGHDA change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Quality of Life Assessment for GHD in Adults questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Lean body mass and fat mass by dual energy x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVLT change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Memory performance measured by the California Verbal Learning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DASS-21 change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Depressive and anxiety symptoms measured by the Depression Anxiety and Stress Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>muscle strength change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>1-RM and hand grip strength (both in kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Aerobic capacity change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>VO2 max</description>
  </other_outcome>
  <other_outcome>
    <measure>Muscle function change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>chair stand test</description>
  </other_outcome>
  <other_outcome>
    <measure>Muscle function change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>stair climb power</description>
  </other_outcome>
  <other_outcome>
    <measure>Fatigue change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>QOL AGHD subsection</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep quality change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Pittsburgh Sleep Quality Index</description>
  </other_outcome>
  <other_outcome>
    <measure>Inflammatory marker changes</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>systemic cytokine levels</description>
  </other_outcome>
  <other_outcome>
    <measure>Anabolic marker changes</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>systemic IGF-1 and IGFBP3 levels (both ng/mL)</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronic pain change</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Brief Pain Inventory</description>
  </other_outcome>
  <enrollment type="Actual">7</enrollment>
  <condition>Adult-Onset Growth Hormone Deficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Veterans being prescribed rhGH replacement for Adult Onset Growth Hormone Deficiency due to&#xD;
        Traumatic Brain Injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. OEF/OIF/OND deployment confirmed by available records&#xD;
&#xD;
          2. history of combat exposure during deployment as determined by a score greater than 1&#xD;
             on the Combat Experiences sub-scale of the Deployment Risk and Resilience Inventory-2&#xD;
             (DRRI-2)&#xD;
&#xD;
          3. age &gt;18 years&#xD;
&#xD;
          4. a history of TBI defined according to the DoD/VA guidelines and characterized by the&#xD;
             Ohio State TBI Inventory&#xD;
&#xD;
          5. history of AGH deficiency diagnosed by: a) a GH stimulatory test; or b) low plasma&#xD;
             IGF-1 level and 3 pituitary hormone deficiencies&#xD;
&#xD;
          6. have been prescribed rhGH replacement by a clinical provider&#xD;
&#xD;
          7. If the Veteran is receiving psychotropic medications he should be on stable doses for&#xD;
             at least 4 weeks before their enrollment in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other untreated pituitary deficiencies [patients with other hormone deficiencies will&#xD;
             have to be on stable replacement for at least three months before including them on&#xD;
             the study; two months of stable replacement is required for hydrocortisone therapy for&#xD;
             adrenal insufficiency]&#xD;
&#xD;
          2. tumors, or other causes of AGHD (e.g. childhood onset GHD, pituitary surgery, tumors,&#xD;
             radiation)&#xD;
&#xD;
          3. history of neurologic or psychiatric disorder such as stroke, spinal cord injury,&#xD;
             bipolar disorder, or schizophrenia that has a significant impact in the Veteran's&#xD;
             functional status and QoL&#xD;
&#xD;
          4. contraindication to rhGH therapy (e.g. hypersensitivity to rhGH or any of the&#xD;
             components of the supplied product, including metacresol, glycerin, or benzyl alcohol)&#xD;
&#xD;
          5. acute medical illness, active infection, neoplastic disease or decompensated chronic&#xD;
             medical illness such as diabetes mellitus (A1c &gt;9%), congestive heart failure or&#xD;
             chronic obstructive pulmonary disease&#xD;
&#xD;
          6. evidence of alcohol dependence, alcohol abuse or drug use disorder during the three&#xD;
             months previous to enrollment in the study&#xD;
&#xD;
          7. evidence of inadequate levels of effort in performing neuropsychological tests as&#xD;
             suggested by scoring less than 41 on Trial I of the Test of Memory and Malingering&#xD;
             (TOMM)&#xD;
&#xD;
          8. due to the decreased specificity of the AGHD diagnostic tests in this setting and&#xD;
             weight/size limitations of the DEXA scanner, we will exclude morbid obese subjects&#xD;
             defined as having a BMI greater than 35 or body weight &gt; 350 lbs&#xD;
&#xD;
          9. use of rhGH in the previous 6 months&#xD;
&#xD;
         10. active or recent (6 months) history of coronary artery or cerebrovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fatigue</keyword>
  <keyword>quality of life</keyword>
  <keyword>depression</keyword>
  <keyword>cognitive function</keyword>
  <keyword>growth hormone</keyword>
  <keyword>traumatic brain injury</keyword>
  <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/NCT02988687
org study id: 00930
nct id: NCT02988687
lead sponsor: 
has dmc: No
This PILOT, NON-INTERVENTIONAL STUDY will follow patients about to start rhGH for a period of
      six months and collect valuable pilot data to evaluate feasibility of a larger study and
      treatment tolerability and compliance. The effect of rhGH on cognitive function, depression,
      fatigue, sleep quality, and QOL will also be collected. This exploratory study will also
      provide important information about recruitment and AGHD screening procedures in military
      settings.
Growth hormone replacement has consistently shown improvements in body composition, exercise
      capacity, endothelial function, inflammatory biomarkers, bone mineral density, lipoprotein
      metabolism, and self-reported quality of Life (QOL) in patients suffering from adult growth
      hormone deficiency (AGHD). One of the causes for AGHD is traumatic brain injury (TBI), a
      condition that affects approximately 20% of Veterans from Operation Enduring Freedom (OEF),
      Operation Iraqi Freedom (OIF), and Operation New Dawn (OND). Because OIF/OEF/OND Veterans are
      a new population, there is a paucity of data regarding the effects of rhGH in these patients.
      The investigators propose to perform a pilot observational study of Veterans with confirmed
      adult growth hormone deficiency (AGHD) due to TBI who have been prescribed recombinant human
      growth hormone (rhGH) replacement in order to determine changes in metabolic parameters and
      QOL induced by rhGH.

      Our hypothesis is that GH replacement will improve QOL and metabolic parameters (glucose,
      insulin resistance, lipids, inflammatory markers, and body composition) in patients with
      confirmed AGHD due to TBI.The primary aim for this proposal is to determine the effects of
      rhGH treatment given daily for 6 months to Veterans with TBI and AGHD on QoL measured by the
      Quality of Life Assessment for GHD in Adults questionnaire (QoL-AGHDA, primary outcome).
      Secondary specific aims for this proposal are to gather high quality pilot data of the
      effects of 6 months of rhGH replacement in Veterans with TBI and AGHD.
observational model: Cohort
time perspective: Prospective
measure: AGHDA change
time frame: baseline to 3 months
description: Quality of Life Assessment for GHD in Adults questionnaire
measure: AGHDA change
time frame: baseline to 6 months
description: Quality of Life Assessment for GHD in Adults questionnaire
measure: Body composition change
time frame: baseline to 6 months
description: Lean body mass and fat mass by dual energy x-ray absorptiometry
measure: CVLT change
time frame: baseline to 6 months
description: Memory performance measured by the California Verbal Learning
measure: DASS-21 change
time frame: baseline to 6 months
description: Depressive and anxiety symptoms measured by the Depression Anxiety and Stress Scale
measure: muscle strength change
time frame: baseline to 6 months
description: 1-RM and hand grip strength (both in kg)
measure: Aerobic capacity change
time frame: baseline to 6 months
description: VO2 max
measure: Muscle function change
time frame: baseline to 6 months
description: chair stand test
measure: Muscle function change
time frame: baseline to 6 months
description: stair climb power
measure: Fatigue change
time frame: baseline to 6 months
description: QOL AGHD subsection
measure: Sleep quality change
time frame: baseline to 6 months
description: Pittsburgh Sleep Quality Index
measure: Inflammatory marker changes
time frame: baseline to 6 months
description: systemic cytokine levels
measure: Anabolic marker changes
time frame: baseline to 6 months
description: systemic IGF-1 and IGFBP3 levels (both ng/mL)
measure: Chronic pain change
time frame: baseline to 6 months
description: Brief Pain Inventory
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No