<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/NCT03018886</url>
  </required_header>
  <id_info>
    <org_study_id>203/2001 and 502/2002</org_study_id>
    <nct_id>NCT03018886</nct_id>
  </id_info>
  <brief_title>Diagnosing Adult Growth Hormone Deficiency</brief_title>
  <official_title>Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus&#xD;
      arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth&#xD;
      hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against&#xD;
      the IS 98/574 from the World Health Organization. A specific aim was to study the effect of&#xD;
      gender and age on the peak GH response in the GHRH+arg test&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult growth hormone deficiency (AGHD) is a clinical entity including increased abdominal fat&#xD;
      mass, decreased muscle mass, low bone density and adverse effects on quality of life and&#xD;
      cardiovascular morbidity. These signs are nonspecific, and accurate diagnosis with laboratory&#xD;
      tests in needed.&#xD;
&#xD;
      The GHRH+arg test is used to diagnose AGHD, but the cut-off values vary based on controls&#xD;
      used. At moment consensus cut-off criteria are BMI specific, but gender and age may also&#xD;
      affect the GH response in the GHRH+arg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2001</start_date>
  <completion_date type="Actual">December 2008</completion_date>
  <primary_completion_date type="Actual">December 2008</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak serum GH (ug/l) by Immulite 2000 Xpi</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum insulin like growth hormone 1 (IGF-1) concentration</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal serum GH (ug/l) by Immulite 2000 Xpi</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>healthy control subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>126 healthy controls underwent the GHRH plus arginine stimulations test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with suspected GH deficiency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GHRH plus arginine test</intervention_name>
    <description>One ug/kg GHRH [GHRH(1-29), GEREF Serono, Italy] was administered as an iv bolus at time 0 min, followed by arginine (L-arginine monohydrochloride, Braun, Melsungen, Germany) 0.5 g/kg (max 30g9 over 30 min. Blood samples were drawn at -15,0,15,30,45,60,75,90 min.</description>
    <arm_group_label>healthy control subjects</arm_group_label>
    <arm_group_label>patients with suspected GH deficiency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        for health patients:&#xD;
&#xD;
          1. age 20-60 years,&#xD;
&#xD;
          2. no symptoms indicative of disease.&#xD;
&#xD;
        for patients:&#xD;
&#xD;
          1. age 16-90 years&#xD;
&#xD;
          2. previous pituitary disease&#xD;
&#xD;
          3. suspicion of growth hormone deficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        for healthy controls:&#xD;
&#xD;
          1. pregnancy,&#xD;
&#xD;
          2. a known or suspected disease,&#xD;
&#xD;
          3. any symptoms indicating disease&#xD;
&#xD;
          4. use of medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esa Hamalainen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tuula Pekkarinen</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>tuula pekkarinen</investigator_full_name>
    <investigator_title>consulting endocrinologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dwarfism, Pituitary</mesh_term>
    <mesh_term>Endocrine System Diseases</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/NCT03018886
org study id: 203/2001 and 502/2002
nct id: NCT03018886
lead sponsor: 
has dmc: No
The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus
      arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth
      hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against
      the IS 98/574 from the World Health Organization. A specific aim was to study the effect of
      gender and age on the peak GH response in the GHRH+arg test
Adult growth hormone deficiency (AGHD) is a clinical entity including increased abdominal fat
      mass, decreased muscle mass, low bone density and adverse effects on quality of life and
      cardiovascular morbidity. These signs are nonspecific, and accurate diagnosis with laboratory
      tests in needed.

      The GHRH+arg test is used to diagnose AGHD, but the cut-off values vary based on controls
      used. At moment consensus cut-off criteria are BMI specific, but gender and age may also
      affect the GH response in the GHRH+arg.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Peak serum GH (ug/l) by Immulite 2000 Xpi
time frame: one year
measure: Serum insulin like growth hormone 1 (IGF-1) concentration
time frame: one year
measure: Basal serum GH (ug/l) by Immulite 2000 Xpi
time frame: one year
arm group label: healthy control subjects
arm group type: Other
description: 126 healthy controls underwent the GHRH plus arginine stimulations test
arm group label: patients with suspected GH deficiency
arm group type: Experimental
description: 34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test
intervention type: Other
intervention name: GHRH plus arginine test
description: One ug/kg GHRH [GHRH(1-29), GEREF Serono, Italy] was administered as an iv bolus at time 0 min, followed by arginine (L-arginine monohydrochloride, Braun, Melsungen, Germany) 0.5 g/kg (max 30g9 over 30 min. Blood samples were drawn at -15,0,15,30,45,60,75,90 min.
arm group label: healthy control subjects
arm group label: patients with suspected GH deficiency
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Esa Hamalainen, MD, PhD
role: Study Director
affiliation: Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: tuula pekkarinen
investigator title: consulting endocrinologist
mesh term: Dwarfism, Pituitary
mesh term: Endocrine System Diseases