<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/NCT02240043</url>
  </required_header>
  <id_info>
    <org_study_id>185/09</org_study_id>
    <secondary_id>Memo n 019/10</secondary_id>
    <nct_id>NCT02240043</nct_id>
  </id_info>
  <brief_title>Growth Hormone Evaluation in the Elderly People</brief_title>
  <official_title>Growth Hormone Evaluation in the Elderly People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic hormone&#xD;
      (ACTH) secretion in elderly without hypothalamic-pituitary disease using the glucagon&#xD;
      stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate some&#xD;
      parameters such as sarcopenia, nutritional state, bone mineral density, frailty criteria with&#xD;
      secretion of GH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      subjects over 65 years old were recruited from the geriatric ambulatory unit of our hospital&#xD;
      to voluntarily participate in a research study concerning the GH and ACTH axis in the&#xD;
      elderly, which included the realization of the glucagon stimulation test as the first phase&#xD;
      of the study.&#xD;
&#xD;
      The GST (Glucagen® Hypokit, Novo Nordisk A/S, Denmark) was the chosen test to assess both&#xD;
      ACTH and GH release because of its few known contraindications and mild side effects. It is a&#xD;
      provocative test to evaluate GH and ACTH axis, i.e, a diagnostic test, without therapeutic&#xD;
      effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Growth Hormone Secretion in the elderly people using glucagon stimulation test (GST)</measure>
    <time_frame>up to one week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ACTH release in the elderly people using GST</measure>
    <time_frame>up to one week</time_frame>
    <description>ACTH: adrenocorticotrophic hormone</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body composition in the elderly people according with GH secretion</measure>
    <time_frame>up to 3 months</time_frame>
    <description>To realize Dual-energy X-ray absorptiometry (DEXA) to evaluate body composition after the realization of the Glucagon stimulation test. It could take some time to be done because of availability of the equipment</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>growth hormone secretion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The elderly had common morbidities peculiar to their age, such as systemic arterial hypertension, diabetes mellitus, Parkinson's disease, initial stages of senile dementia, and osteoporosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>growth hormone secretion</intervention_name>
    <description>The glucagon stimulation test (GST) was performed by intramuscular injection of 1 mg of glucagon (Glucagen® Hypokit, Novo Nordisk A/S, Denmark). The blood samples were collected at baseline and after 90 minutes, 120 minutes, 150 minutes and 180 minutes of glucagon injection for GH and cortisol measurements. The subjects were recumbent during the test, and a cannula was maintained in a vein in the arm or forearm with a saline solution slowly infused to avoid multiple punctures.</description>
    <arm_group_label>growth hormone secretion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elderly people above 65 years old with comorbidities peculiar to their age (such as&#xD;
             hypertension, diabetes, dyslipidemia, parkinson disease) or without comorbidities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pituitary disease, severe acute disease, terminal renal chronic disease, active&#xD;
             malignant cancer, the presence of any other disease that could interfere with the&#xD;
             somatotrophic axis evaluation, and the contraindications for glucagon administration&#xD;
             (pheochromocytoma, insulinoma and malnourishment).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Flávia L Conceição, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitário Clementino Fraga Filho - UFRJ</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio de Janeiro</investigator_affiliation>
    <investigator_full_name>Ana Beatriz Winter Tavares</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
  </intervention_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/NCT02240043
org study id: 185/09
secondary id: Memo n 019/10
nct id: NCT02240043
lead sponsor: 
has dmc: No
The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic hormone
      (ACTH) secretion in elderly without hypothalamic-pituitary disease using the glucagon
      stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate some
      parameters such as sarcopenia, nutritional state, bone mineral density, frailty criteria with
      secretion of GH.
subjects over 65 years old were recruited from the geriatric ambulatory unit of our hospital
      to voluntarily participate in a research study concerning the GH and ACTH axis in the
      elderly, which included the realization of the glucagon stimulation test as the first phase
      of the study.

      The GST (Glucagen® Hypokit, Novo Nordisk A/S, Denmark) was the chosen test to assess both
      ACTH and GH release because of its few known contraindications and mild side effects. It is a
      provocative test to evaluate GH and ACTH axis, i.e, a diagnostic test, without therapeutic
      effects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Growth Hormone Secretion in the elderly people using glucagon stimulation test (GST)
time frame: up to one week
measure: ACTH release in the elderly people using GST
time frame: up to one week
description: ACTH: adrenocorticotrophic hormone
measure: Body composition in the elderly people according with GH secretion
time frame: up to 3 months
description: To realize Dual-energy X-ray absorptiometry (DEXA) to evaluate body composition after the realization of the Glucagon stimulation test. It could take some time to be done because of availability of the equipment
arm group label: growth hormone secretion
arm group type: Other
description: The elderly had common morbidities peculiar to their age, such as systemic arterial hypertension, diabetes mellitus, Parkinson's disease, initial stages of senile dementia, and osteoporosis.
intervention type: Other
intervention name: growth hormone secretion
description: The glucagon stimulation test (GST) was performed by intramuscular injection of 1 mg of glucagon (Glucagen® Hypokit, Novo Nordisk A/S, Denmark). The blood samples were collected at baseline and after 90 minutes, 120 minutes, 150 minutes and 180 minutes of glucagon injection for GH and cortisol measurements. The subjects were recumbent during the test, and a cannula was maintained in a vein in the arm or forearm with a saline solution slowly infused to avoid multiple punctures.
arm group label: growth hormone secretion
criteria: 
gender: All
minimum age: 65 Years
maximum age: 95 Years
healthy volunteers: No
last name: Flávia L Conceição, PhD
role: Study Director
affiliation: Hospital Universitário Clementino Fraga Filho - UFRJ
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio de Janeiro
investigator full name: Ana Beatriz Winter Tavares
investigator title: MD
mesh term: Hormones