<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/NCT03033121</url>
  </required_header>
  <id_info>
    <org_study_id>3-wk-GH</org_study_id>
    <nct_id>NCT03033121</nct_id>
  </id_info>
  <brief_title>Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children</brief_title>
  <acronym>GH 3 wk dose</acronym>
  <official_title>More Favorable Metabolic Impact of Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Palermo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Palermo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered&#xD;
      daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is&#xD;
      often not complied. The auxological effect of three injections per week (TIW) regimen is&#xD;
      controversial, while the metabolic effects were never evaluated in children. The objective of&#xD;
      this study was to evaluate whether two different regimens of weekly injections could lead to&#xD;
      similar auxological and metabolic effects in children with GHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr)&#xD;
      were randomly assigned to receive daily (group A, No 16) or three injections per week (group&#xD;
      B, No 16) GH therapy for 12 months.&#xD;
&#xD;
      Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an&#xD;
      oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition&#xD;
      index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the&#xD;
      quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI)&#xD;
      were evaluated in the two groups of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>height</measure>
    <time_frame>12 months</time_frame>
    <description>height (standard deviation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight</measure>
    <time_frame>12 months</time_frame>
    <description>weight (kilograms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body mass index</measure>
    <time_frame>12 months</time_frame>
    <description>body mass index (kilograms/m2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin growth factor-I</measure>
    <time_frame>12 months</time_frame>
    <description>insulin growth factor (IGF)-I (ug/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>glucose</measure>
    <time_frame>12 months</time_frame>
    <description>glucose (mmol/l) during oral glucose tolerance test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>insulin</measure>
    <time_frame>12 months</time_frame>
    <description>insulin (uU/ml) during oral glucose tolerance test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>glycated hemoglobin</measure>
    <time_frame>12 months</time_frame>
    <description>glycated hemoglobin (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ISI Matsuda</measure>
    <time_frame>12 months</time_frame>
    <description>Insulin Sensitivity Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral disposition index</measure>
    <time_frame>12 months</time_frame>
    <description>Oral Disposition Index (DIo)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Homa IR</measure>
    <time_frame>12 months</time_frame>
    <description>The homeostatic model assessment of insulin resistance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>12 months</time_frame>
    <description>Low Density Lipoprotein cholesterol (mmol/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>12 months</time_frame>
    <description>triglycerides (mmol/l)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Growth Hormone Treatment</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sixteen growth hormone (GH) deficiency children were assigned to receive daily growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sixteen growth hormone (GH) deficiency children were assigned to receive three time weekly growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Growth Hormone</intervention_name>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Growth hormone deficiency clinically and biochemically demonstrated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children affected by multiple pituitary hormone deficiency or receiving any other kind&#xD;
             of hormonal replacement therapy or drug and GHD children with a shorter follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Endocrinology - University of Palermo</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>October 25, 2017</last_update_submitted>
  <last_update_submitted_qc>October 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Palermo</investigator_affiliation>
    <investigator_full_name>Carla Giordano</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>growth hormone</keyword>
  <keyword>children</keyword>
  <keyword>metabolism</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
  </intervention_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/NCT03033121
org study id: 3-wk-GH
nct id: NCT03033121
lead sponsor: 
has dmc: Yes
Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered
      daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is
      often not complied. The auxological effect of three injections per week (TIW) regimen is
      controversial, while the metabolic effects were never evaluated in children. The objective of
      this study was to evaluate whether two different regimens of weekly injections could lead to
      similar auxological and metabolic effects in children with GHD.
Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr)
      were randomly assigned to receive daily (group A, No 16) or three injections per week (group
      B, No 16) GH therapy for 12 months.

      Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an
      oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition
      index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the
      quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI)
      were evaluated in the two groups of patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: height
time frame: 12 months
description: height (standard deviation)
measure: weight
time frame: 12 months
description: weight (kilograms)
measure: body mass index
time frame: 12 months
description: body mass index (kilograms/m2)
measure: Insulin growth factor-I
time frame: 12 months
description: insulin growth factor (IGF)-I (ug/L)
measure: glucose
time frame: 12 months
description: glucose (mmol/l) during oral glucose tolerance test
measure: insulin
time frame: 12 months
description: insulin (uU/ml) during oral glucose tolerance test
measure: glycated hemoglobin
time frame: 12 months
description: glycated hemoglobin (%)
measure: ISI Matsuda
time frame: 12 months
description: Insulin Sensitivity Index
measure: Oral disposition index
time frame: 12 months
description: Oral Disposition Index (DIo)
measure: Homa IR
time frame: 12 months
description: The homeostatic model assessment of insulin resistance
measure: LDL cholesterol
time frame: 12 months
description: Low Density Lipoprotein cholesterol (mmol/l)
measure: Triglycerides
time frame: 12 months
description: triglycerides (mmol/l)
arm group label: group A
arm group type: Active Comparator
description: Sixteen growth hormone (GH) deficiency children were assigned to receive daily growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.
arm group label: group B
arm group type: Active Comparator
description: Sixteen growth hormone (GH) deficiency children were assigned to receive three time weekly growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.
intervention type: Drug
intervention name: Growth Hormone
arm group label: group A
arm group label: group B
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Carla Giordano
investigator title: Professor
mesh term: Hormones
sharing ipd: No