<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/NCT03807076</url>
  </required_header>
  <id_info>
    <org_study_id>Acromegaly GA-9</org_study_id>
    <nct_id>NCT03807076</nct_id>
  </id_info>
  <brief_title>Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor</brief_title>
  <acronym>GA-9</acronym>
  <official_title>Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Herlev and Gentofte Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: To determine the importance of the GIP system in patients with acromegaly who has&#xD;
      paradoxical growth hormone secretion during an oral glucose tolerance test (OGTT) using a GIP&#xD;
      antagonist (GIP-A).&#xD;
&#xD;
      Thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin&#xD;
      levels will be included in a placebo-controlled cross-over study. The study consists of two&#xD;
      study days with concomitant infusions of A) GIP-A or B) saline (placebo).&#xD;
&#xD;
      A paradoxical growth hormone secretion to an OGTT is here defined as an increase in plasma&#xD;
      growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the&#xD;
      literature.&#xD;
&#xD;
      Regazzo et al. (2017) European Journal of Endocrinology 176, 543-553 Mukai et al. (2018) The&#xD;
      Journal of Clinical Endocrinology and Metabolism 104(5), 1637-1644 Hage et al. (2019) The&#xD;
      Journal of Clinical Endocrinology and Metabolism 104(5), 1777-1787 Scaroni et al. (2019) J&#xD;
      Clin Endocrinol Metab 104(3), 856-862&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 13, 2019</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Growth hormone levels</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma growth hormone area under the curve (AUC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose levels</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma glucose AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GIP levels</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma GIP AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin levels</measure>
    <time_frame>240 min</time_frame>
    <description>Serum insulin AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-peptide levels</measure>
    <time_frame>240 min</time_frame>
    <description>Serum C-peptide AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin-like growth factor-1 (IGF-1) levels</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma IGF-1 AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free fatty acids (FFA) levels</measure>
    <time_frame>240 min</time_frame>
    <description>serum FFA AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucagon levels</measure>
    <time_frame>240 min</time_frame>
    <description>plasma glucagon AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ghrelin levels</measure>
    <time_frame>240 min</time_frame>
    <description>plasma ghrelin AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GLP-1 levels</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma GLP-1 AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GLP-2 levels</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma GLP-2 AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma cholesterol</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma cholesterol AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma triglyceride</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma triglyceride AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma TSH</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma TSH AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma prolactin</measure>
    <time_frame>240 min</time_frame>
    <description>Plasma prolactin AUC</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Acromegaly Due to Pituitary Adenoma</condition>
  <arm_group>
    <arm_group_label>GIP-A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Infusion of GIP-A alone as a study tool.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GIP-A</intervention_name>
    <description>GIP-A</description>
    <arm_group_label>GIP-A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients under clinical investigation of acromegaly disease with normal kidney&#xD;
             function, liver function and hemoglobin levels.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe&#xD;
             heart disease, uncontrolled high blood pressure (&gt;170/100 mmHg), current pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette H Jensen, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Biomedical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Biomedical Sciences</name>
      <address>
        <city>Copenhagen</city>
        <zip>2200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>May 27, 2023</last_update_submitted>
  <last_update_submitted_qc>May 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Mette Høy Jensen</investigator_full_name>
    <investigator_title>Industrial PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Pituitary Neoplasms</mesh_term>
    <mesh_term>Growth Hormone-Secreting Pituitary Adenoma</mesh_term>
    <mesh_term>Acromegaly</mesh_term>
    <mesh_term>Pituitary Diseases</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/NCT03807076
org study id: Acromegaly GA-9
nct id: NCT03807076
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma
Aim: To determine the importance of the GIP system in patients with acromegaly who has
      paradoxical growth hormone secretion during an oral glucose tolerance test (OGTT) using a GIP
      antagonist (GIP-A).

      Thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin
      levels will be included in a placebo-controlled cross-over study. The study consists of two
      study days with concomitant infusions of A) GIP-A or B) saline (placebo).

      A paradoxical growth hormone secretion to an OGTT is here defined as an increase in plasma
      growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the
      literature.

      Regazzo et al. (2017) European Journal of Endocrinology 176, 543-553 Mukai et al. (2018) The
      Journal of Clinical Endocrinology and Metabolism 104(5), 1637-1644 Hage et al. (2019) The
      Journal of Clinical Endocrinology and Metabolism 104(5), 1777-1787 Scaroni et al. (2019) J
      Clin Endocrinol Metab 104(3), 856-862
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Growth hormone levels
time frame: 240 min
description: Plasma growth hormone area under the curve (AUC)
measure: Glucose levels
time frame: 240 min
description: Plasma glucose AUC
measure: GIP levels
time frame: 240 min
description: Plasma GIP AUC
measure: Insulin levels
time frame: 240 min
description: Serum insulin AUC
measure: C-peptide levels
time frame: 240 min
description: Serum C-peptide AUC
measure: Insulin-like growth factor-1 (IGF-1) levels
time frame: 240 min
description: Plasma IGF-1 AUC
measure: Free fatty acids (FFA) levels
time frame: 240 min
description: serum FFA AUC
measure: Glucagon levels
time frame: 240 min
description: plasma glucagon AUC
measure: Ghrelin levels
time frame: 240 min
description: plasma ghrelin AUC
measure: GLP-1 levels
time frame: 240 min
description: Plasma GLP-1 AUC
measure: GLP-2 levels
time frame: 240 min
description: Plasma GLP-2 AUC
measure: Plasma cholesterol
time frame: 240 min
description: Plasma cholesterol AUC
measure: Plasma triglyceride
time frame: 240 min
description: Plasma triglyceride AUC
measure: Plasma TSH
time frame: 240 min
description: Plasma TSH AUC
measure: Plasma prolactin
time frame: 240 min
description: Plasma prolactin AUC
arm group label: GIP-A
arm group type: Other
description: Infusion of GIP-A alone as a study tool.
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline
intervention type: Other
intervention name: GIP-A
description: GIP-A
arm group label: GIP-A
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Mette H Jensen, MSc
role: Principal Investigator
affiliation: Department of Biomedical Sciences
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Mette Høy Jensen
investigator title: Industrial PhD student
mesh term: Adenoma
mesh term: Pituitary Neoplasms
mesh term: Growth Hormone-Secreting Pituitary Adenoma
mesh term: Acromegaly
mesh term: Pituitary Diseases
sharing ipd: No