<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/NCT02248779</url>
  </required_header>
  <id_info>
    <org_study_id>14-202</org_study_id>
    <nct_id>NCT02248779</nct_id>
  </id_info>
  <brief_title>Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation</brief_title>
  <official_title>Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to better understand the risk factors and causes of diabetes in&#xD;
      people who received radiation to the abdomen as children. The investigators hope this&#xD;
      information will allow them to improve how they screen people at risk for diabetes and how&#xD;
      they treat patients in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2014</start_date>
  <completion_date type="Actual">October 9, 2019</completion_date>
  <primary_completion_date type="Actual">October 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>characterize β cell function</measure>
    <time_frame>2 years</time_frame>
    <description>we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>insulin sensitivity</measure>
    <time_frame>2 years</time_frame>
    <description>we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Childhood Cancer Survivors Treated With Abdominal Radiation</condition>
  <arm_group>
    <arm_group_label>treated &lt; 20 years prior to study enrollment</arm_group_label>
    <description>The following information will be gathered:&#xD;
A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load.&#xD;
C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c.&#xD;
All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treated ≥ 20 years prior to study enrollment</arm_group_label>
    <description>The following information will be gathered:&#xD;
A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load.&#xD;
C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c.&#xD;
All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Childhood cancer survivors followed by the Pediatric Long-Term Follow-Up Program or Adult&#xD;
        Long-Term Follow-Up Program will be recruited for the current study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of childhood cancer between 0-21 years of age&#xD;
&#xD;
          -  Prior treatment with abdominal radiation at MSKCC&#xD;
&#xD;
          -  Two or more years from completion of therapy&#xD;
&#xD;
          -  Records of cancer diagnosis and treatment (including radiation records) available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known diagnosis of diabetes&#xD;
&#xD;
          -  Previous treatment with any radiation impacting the brain (cranial radiation,&#xD;
             craniospinal radiation, total body irradiation)&#xD;
&#xD;
          -  Neurocognitive deficits that impair ability to give informed consent or assent&#xD;
&#xD;
          -  Patients predicted to have difficult intravenous access, who will likely require&#xD;
             multiple venipuncture attempts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danielle N. Friedman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>October 14, 2019</last_update_submitted>
  <last_update_submitted_qc>October 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Risk</keyword>
  <keyword>14-202</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</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/NCT02248779
org study id: 14-202
nct id: NCT02248779
lead sponsor: 
The purpose of this study is to better understand the risk factors and causes of diabetes in
      people who received radiation to the abdomen as children. The investigators hope this
      information will allow them to improve how they screen people at risk for diabetes and how
      they treat patients in the future.
observational model: Cohort
time perspective: Cross-Sectional
measure: characterize β cell function
time frame: 2 years
description: we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.
measure: insulin sensitivity
time frame: 2 years
description: we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.
arm group label: treated < 20 years prior to study enrollment
description: The following information will be gathered:
A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load.
C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c.
All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated.
arm group label: treated ≥ 20 years prior to study enrollment
description: The following information will be gathered:
A. Height, weight, waist circumference, blood pressure B. Oral glucose tolerance testing (OGTT) where in participants will ingest a standard oral glucose load (75 grams) in liquid formulation after an overnight fast. Blood samples for glucose and insulin concentrations will be taken at 0, 30, 60, 90, and 120 minutes post-glucose load.
C. Glutamic acid decarboxylase (GAD), islet cell (ICA-512), and insulin autoantibody (IAA) titers as well as serum adiponectin and hemoglobin A1c.
All enrolled patients will have a discussion with an LTFU doctor regarding the results of testing. Counseling and referral to a specialist will be provided if indicated.
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Danielle N. Friedman, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Insulin Resistance