<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/NCT03301519</url>
  </required_header>
  <id_info>
    <org_study_id>HS 013025</org_study_id>
    <nct_id>NCT03301519</nct_id>
  </id_info>
  <brief_title>Genetics of Beta Cell Failure in Mexican Americans</brief_title>
  <official_title>Genetics of Beta Cell Failure in Mexican Americans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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>
      This is a family based genotype-phenotype study designed to assess genetic and environmental&#xD;
      influences on obesity, insulin resistance and beta cell function in the context of&#xD;
      gestational diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mexican American women with prior gestational diabetes and their first degree relatives and&#xD;
      Mexican American women with prior normal glucose tolerance in pregnancy are studied with&#xD;
      detailed phenotyping consisting of oral and intravenous glucose tolerance tests, body&#xD;
      composition studies, diet and physical activity assessments, and circulating biomarkers&#xD;
      potentially related to obesity, insulin resistance, pancreatic beta cell function,&#xD;
      gestational diabetes and type 2 diabetes. Spouses of the gestational diabetic and control&#xD;
      probands are studied with oral glucose tolerance tests. Offspring of the gestational and&#xD;
      control probands have fasting glucose determinations. All participants provide DNA for&#xD;
      genetics testing. A subset of the gestational diabetic probands and their first degree&#xD;
      relatives return 3-5 years after baseline testing for repeat phenotyping.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2001</start_date>
  <completion_date type="Actual">May 31, 2013</completion_date>
  <primary_completion_date type="Actual">May 31, 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pancreatic Beta Cell Compensation for Insulin Resistance</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>Disposition index from intravenous glucose tolerance test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin Senstivity</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>Si from computer modeled intravenous glucose tolerance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Insulin Release</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>Incremental area under insulin curve during first 10 minutes intravenous glucose tolerance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose tolerance</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>normal, impaired or diabetic glucose level determined using American Diabetes Associate criteria applied to glucose levels from a 2-hour, 75 gram oral glucose tolerance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes type 2</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>Fasting glucose &gt;125 mg/dl and/or 2-hour glucose on 75 gram oral glucose tolerance test &gt;199 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>Measured by semi-quantitative Harvard Food Frequency Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>Measured by Multi-ethnic Cohort Physical Activity Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Fat</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>Percent body fat measured by dual photon X-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating adipokine levels</measure>
    <time_frame>Single time point for primary cohort, repeated 4.5 years later in subset</time_frame>
    <description>Fasting levels of approximately 20 adipocytokines</description>
  </secondary_outcome>
  <enrollment type="Actual">1250</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Diabetes Type 2</condition>
  <condition>Insulin Resistance</condition>
  <condition>Beta Cell Function</condition>
  <condition>Genetics</condition>
  <condition>Nutrition</condition>
  <condition>Physical Activity</condition>
  <condition>Adipokines</condition>
  <condition>Obesity</condition>
  <condition>Air Pollution</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA, plasma samples from oral glucose tolerance test, plasma samples from intravenous glucose&#xD;
      tolerance test&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        See Inclusion and Exclusion Criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          1. Probands with Prior Gestational Diabetes Mellitus (&quot;GDM PROBANDS&quot;)&#xD;
&#xD;
               -  Mexican American (parents and at least 3/4 four grandparents&#xD;
&#xD;
               -  age &gt;18 years&#xD;
&#xD;
               -  GDM in singleton pregnancy in prior 5 years&#xD;
&#xD;
               -  impaired glucose levels or sum of five OGTT glucose values &gt;625 mg/dl on 75 gram&#xD;
                  oral glucose tolerance test&#xD;
&#xD;
               -  Fasting plasma glucose &lt;126 mg/dl&#xD;
&#xD;
               -  At least two adult siblings of cousin not known to have diabetes and available&#xD;
                  for phenotyping; .&#xD;
&#xD;
          2. Siblings and Cousins of GDM Probands&#xD;
&#xD;
               -  Full sibling or first cousin of GDM proband&#xD;
&#xD;
               -  Age &gt;18 yrs&#xD;
&#xD;
               -  Fasting plasma glucose &lt;126 mg/dl.&#xD;
&#xD;
          3. Parents, Uncles and Aunts of GDM Probands&#xD;
&#xD;
               -  Full blooded parent, uncle or aunt of GDM proband&#xD;
&#xD;
          4. Control Proband&#xD;
&#xD;
               -  Mexican American as defined for GDM probands&#xD;
&#xD;
               -  One glucose challenge test result &lt;120 mg/dl at &gt;24 weeks gestation&#xD;
&#xD;
               -  No diabetes in first degree relative&#xD;
&#xD;
               -  Frequency matched to GDM probands by distributions of age, BMI and parity.&#xD;
&#xD;
          5. Spouse of GDM or Control Proband&#xD;
&#xD;
               -  Spouse of GDM proband&#xD;
&#xD;
               -  Age &gt;18&#xD;
&#xD;
               -  At least one child with proband able to provide DNA&#xD;
&#xD;
          6. Child of Proband&#xD;
&#xD;
               -  Child of GDM or control proband and spouse who provided DNA&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          1. PROBANDS (GDM OR CONTROL):&#xD;
&#xD;
               -  Chronic medical illness or medication known to alter glucose/insulin metabolism&#xD;
&#xD;
               -  Current pregnancy or breastfeeding&#xD;
&#xD;
               -  Ilicit drug or alcohol abuse,&#xD;
&#xD;
               -  Inability or unwillingness to give informed consent.&#xD;
&#xD;
          2. SIBLINGS AND COUSINS OF PROBANDS:&#xD;
&#xD;
               -  Chronic medical illness or medication known to affect glucose/insulin metabolism&#xD;
&#xD;
               -  Current pregnancy or breastfeeding,&#xD;
&#xD;
               -  Ilicit drug or alcohol abuse&#xD;
&#xD;
               -  Inability or unwillingness to give informed consent.&#xD;
&#xD;
          3. PARENTS OF PROBANDS&#xD;
&#xD;
               -  Inability or unwillingness to give informed consent.&#xD;
&#xD;
          4. SPOUSE OF GDM or CONTROL PROBAND&#xD;
&#xD;
               -  Inability or unwillingness to give informed consent.&#xD;
&#xD;
          5. CHILD OF GDM or CONTROL PROBAND&#xD;
&#xD;
               -  Lack of parent consent or child assent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Thomas Buchanan</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03301519
org study id: HS 013025
nct id: NCT03301519
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a family based genotype-phenotype study designed to assess genetic and environmental
      influences on obesity, insulin resistance and beta cell function in the context of
      gestational diabetes.
Mexican American women with prior gestational diabetes and their first degree relatives and
      Mexican American women with prior normal glucose tolerance in pregnancy are studied with
      detailed phenotyping consisting of oral and intravenous glucose tolerance tests, body
      composition studies, diet and physical activity assessments, and circulating biomarkers
      potentially related to obesity, insulin resistance, pancreatic beta cell function,
      gestational diabetes and type 2 diabetes. Spouses of the gestational diabetic and control
      probands are studied with oral glucose tolerance tests. Offspring of the gestational and
      control probands have fasting glucose determinations. All participants provide DNA for
      genetics testing. A subset of the gestational diabetic probands and their first degree
      relatives return 3-5 years after baseline testing for repeat phenotyping.
observational model: Cohort
time perspective: Prospective
measure: Pancreatic Beta Cell Compensation for Insulin Resistance
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: Disposition index from intravenous glucose tolerance test
measure: Insulin Senstivity
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: Si from computer modeled intravenous glucose tolerance test
measure: Acute Insulin Release
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: Incremental area under insulin curve during first 10 minutes intravenous glucose tolerance test
measure: Glucose tolerance
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: normal, impaired or diabetic glucose level determined using American Diabetes Associate criteria applied to glucose levels from a 2-hour, 75 gram oral glucose tolerance test
measure: Diabetes type 2
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: Fasting glucose >125 mg/dl and/or 2-hour glucose on 75 gram oral glucose tolerance test >199 mg/dl
measure: Dietary Intake
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: Measured by semi-quantitative Harvard Food Frequency Questionnaire
measure: Physical Activity
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: Measured by Multi-ethnic Cohort Physical Activity Questionnaire
measure: Body Fat
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: Percent body fat measured by dual photon X-ray absorptiometry
measure: Circulating adipokine levels
time frame: Single time point for primary cohort, repeated 4.5 years later in subset
description: Fasting levels of approximately 20 adipocytokines
DNA, plasma samples from oral glucose tolerance test, plasma samples from intravenous glucose
      tolerance test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Thomas Buchanan
investigator title: Professor of Medicine
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Insulin Resistance
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No