<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/NCT01718080</url>
  </required_header>
  <id_info>
    <org_study_id>H-29652</org_study_id>
    <secondary_id>NIH 1K126K63691</secondary_id>
    <nct_id>NCT01718080</nct_id>
  </id_info>
  <brief_title>The Effects of Puberty and Weight on Sugar Metabolism in Children</brief_title>
  <official_title>The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</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>
      Our goal is to investigate how hormones that control blood sugar, hunger, and stomach&#xD;
      emptying change with puberty and being overweight. These substances change with a meal.&#xD;
&#xD;
        -  For this, we need to compare lean and overweight children.&#xD;
&#xD;
        -  We need to study them before and during puberty.&#xD;
&#xD;
        -  All children in the study will be tested before and after a liquid meal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overweight and Lean Children Sugar Metabolism Before and During Puberty</measure>
    <time_frame>4 hours</time_frame>
    <description>Too much weight gain can cause changes in the substances that control blood sugar and hunger in the body. Scientists need to compare these substances in lean and overweight children before and during puberty. These substances can be measured before and after a meal in the blood and in the urine. The way your stomach moves food can change your sugar levels. We want to understand how diabetes develops by studying these things. This can help find better ways to prevent and treat diabetes.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">83</enrollment>
  <condition>Overweight</condition>
  <condition>Leanness</condition>
  <condition>Adolescent</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Healthy lean children before puberty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Otherwise healthy overweight children before puberty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>Healthy lean adolescents in mid to late puberty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <description>Otherwise healthy overweight adolescents in mid to late puberty</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Prepubertal and pubertal subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All groups:&#xD;
&#xD;
        Healthy lean and otherwise healthy overweight children and adolescents between the ages of&#xD;
        8 and 17.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Same for all groups&#xD;
&#xD;
        The subjects will be excluded if they have:&#xD;
&#xD;
          -  a history of chronic disease&#xD;
&#xD;
          -  allergy to acetaminophen&#xD;
&#xD;
          -  evidence or history of chemical abuse&#xD;
&#xD;
          -  abnormal lab values&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luisa M. Rodriguez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>April 21, 2017</last_update_submitted>
  <last_update_submitted_qc>April 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Luisa M. Rodriguez</investigator_full_name>
    <investigator_title>The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia</investigator_title>
  </responsible_party>
  <keyword>Obese, Lean, Pubertal, Prepubertal, Glucose, Adolescents, Type 2 Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT01718080
org study id: H-29652
secondary id: NIH 1K126K63691
nct id: NCT01718080
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our goal is to investigate how hormones that control blood sugar, hunger, and stomach
      emptying change with puberty and being overweight. These substances change with a meal.

        -  For this, we need to compare lean and overweight children.

        -  We need to study them before and during puberty.

        -  All children in the study will be tested before and after a liquid meal.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Overweight and Lean Children Sugar Metabolism Before and During Puberty
time frame: 4 hours
description: Too much weight gain can cause changes in the substances that control blood sugar and hunger in the body. Scientists need to compare these substances in lean and overweight children before and during puberty. These substances can be measured before and after a meal in the blood and in the urine. The way your stomach moves food can change your sugar levels. We want to understand how diabetes develops by studying these things. This can help find better ways to prevent and treat diabetes.
arm group label: Group A
description: Healthy lean children before puberty
arm group label: Group B
description: Otherwise healthy overweight children before puberty
arm group label: Group C
description: Healthy lean adolescents in mid to late puberty
arm group label: Group D
description: Otherwise healthy overweight adolescents in mid to late puberty
plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luisa M. Rodriguez, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Luisa M. Rodriguez
investigator title: The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia
mesh term: Overweight
sharing ipd: No