<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/NCT03771066</url>
  </required_header>
  <id_info>
    <org_study_id>2018-149-CP</org_study_id>
    <nct_id>NCT03771066</nct_id>
  </id_info>
  <brief_title>Bisphenol A and Muscle Insulin Sensitivity</brief_title>
  <official_title>Randomized Trial Examining Oral Consumption of Bisphenol A on Type 2 Diabetes Risk Markers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>California Polytechnic State University-San Luis Obispo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>California Polytechnic State University-San Luis Obispo</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>
      This study examine oral bisphenol A consumption on muscle insulin sensitivity and hepatic&#xD;
      glucose suppression. Half of the participants will receive a diet plus BPA and the other half&#xD;
      will receive a diet plus no bisphenol A.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evidence linking bisphenol A exposure with diabetes risk remains mainly associative in&#xD;
      nature, and mechanism linking bisphenol A to type 2 diabetes remains unclear. The&#xD;
      investigator's preliminary data suggests that in young adults, single oral BPA consumption&#xD;
      significantly decreased glucose, insulin, and C-Peptide responses to an oral glucose&#xD;
      tolerance test, suggesting that immediate consumption of bisphenol A has an effect on muscle&#xD;
      insulin sensitivity, hepatic glucose suppression and/or digestion and absorption to lower&#xD;
      blood glucose, insulin, and C-Peptide concentrations. The present experimental study&#xD;
      evaluating the effects of bisphenol A over several days on the pathogenesis of type 2&#xD;
      diabetes will directly assess each of these potential mechanisms using gold standard measures&#xD;
      (euglycemic hyperinsulinemic clamp technique and hepatic glucose suppression with glucose&#xD;
      stable isotope infusion, and fecal microbiota).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This experimental study is a 2-group randomized, clinical trial comparing a 4-day energy balance diet plus oral BPA consumption at 50 ug/kg body weight (Diet+BPA) vs. 4-day energy balance diet plus oral placebo consumption (Diet+No BPA). Forty participants will be randomized to Diet+BPA and Diet+No BPA and will reside in a supervised environment at Cal Poly's sleep research facilities for 6 days (2-day baseline run-in, followed by 4-day treatment). Main outcome measures (muscle insulin sensitivity and hepatic glucose suppression) will be assessed at baseline and treatment periods.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in rate of glucose disposal</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in rate of glucose appearance</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of insulin</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Fasting blood sample for insulin concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of glucose</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Fasting blood sample for glucose concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of c-peptide</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Fasting blood sample for c-peptide concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of proinsulin</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Fasting blood sample for proinsulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of adiponectin</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Fasting blood sample for adiponectin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of 17-beta estradiol</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Fasting blood sample for 17-beta estradiol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of firmicutes</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Fecal microbiome concentration of firmicutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of clostridia</measure>
    <time_frame>Baseline and 4 days</time_frame>
    <description>Fecal microbiome concentration of clostridia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Insulin Sensitivity</condition>
  <condition>Glucose Metabolism Disorders</condition>
  <condition>Microtia</condition>
  <arm_group>
    <arm_group_label>Diet plus bisphenol A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a 4-day diet plus no bisphenol A.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>bisphenol A</intervention_name>
    <description>Vanilla wafer cookie with bisphenol A administered</description>
    <arm_group_label>Diet plus bisphenol A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Vanilla wafer cookie with no bisphenol A</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-dieting&#xD;
&#xD;
          -  sedentary (≤3 hour/week of aerobic exercise)&#xD;
&#xD;
          -  normal-weight (BMI = 18.5 to 24.9 kg/m2)&#xD;
&#xD;
          -  weight-stable for the previous 6 months&#xD;
&#xD;
          -  free of any metabolic or chronic disease&#xD;
&#xD;
          -  non-smoking, and sedentary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin A1C based on the American Diabetes Association guidelines of 5.7 to 6.4%&#xD;
             (Prediabetes) or &gt;6.4% (Diabetes)&#xD;
&#xD;
          -  impaired glucose tolerance&#xD;
&#xD;
          -  type 1 diabetes&#xD;
&#xD;
          -  type 2 diabetes&#xD;
&#xD;
          -  colitis or any inflammatory bowel condition&#xD;
&#xD;
          -  neurologic or psychiatric conditions&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  special diets (e.g. vegetarian, low-carbohydrate, Paleolithic, etc.)&#xD;
&#xD;
          -  pregnant women or women trying to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd Hagobian, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>California Polytechnic State University-San Luis Obispo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hannah Brunner-Gaydos</last_name>
    <role>Study Director</role>
    <affiliation>California Polytechnic State University-San Luis Obispo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Todd Hagobian, PhD</last_name>
    <phone>805-756-7511</phone>
    <email>thagobia@calpoly.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adam seal</last_name>
    <phone>805-756-5573</phone>
    <email>adseal@calpoly.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>California Polytechnic State University</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Todd Hagobian, PhD</last_name>
      <phone>805-756-7511</phone>
      <email>thagobia@calpoly.edu</email>
    </contact>
    <contact_backup>
      <last_name>Hannah Brunner-Gaydos</last_name>
      <phone>805-756-5573</phone>
      <email>hbrunner@calpoly.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>California Polytechnic State University-San Luis Obispo</investigator_affiliation>
    <investigator_full_name>Todd Hagobian</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>bisphenol A</keyword>
  <keyword>diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Microtia</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bisphenol A</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of study completion, and will be available indefinitely.</ipd_time_frame>
    <ipd_access_criteria>Data access will be freely available for download on the Cal Poly Digital Commons website. Requestors will be required to sign a data access agreement.</ipd_access_criteria>
    <ipd_url>https://digitalcommons.calpoly.edu</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03771066/Prot_SAP_ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03771066
org study id: 2018-149-CP
nct id: NCT03771066
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study examine oral bisphenol A consumption on muscle insulin sensitivity and hepatic
      glucose suppression. Half of the participants will receive a diet plus BPA and the other half
      will receive a diet plus no bisphenol A.
Evidence linking bisphenol A exposure with diabetes risk remains mainly associative in
      nature, and mechanism linking bisphenol A to type 2 diabetes remains unclear. The
      investigator's preliminary data suggests that in young adults, single oral BPA consumption
      significantly decreased glucose, insulin, and C-Peptide responses to an oral glucose
      tolerance test, suggesting that immediate consumption of bisphenol A has an effect on muscle
      insulin sensitivity, hepatic glucose suppression and/or digestion and absorption to lower
      blood glucose, insulin, and C-Peptide concentrations. The present experimental study
      evaluating the effects of bisphenol A over several days on the pathogenesis of type 2
      diabetes will directly assess each of these potential mechanisms using gold standard measures
      (euglycemic hyperinsulinemic clamp technique and hepatic glucose suppression with glucose
      stable isotope infusion, and fecal microbiota).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This experimental study is a 2-group randomized, clinical trial comparing a 4-day energy balance diet plus oral BPA consumption at 50 ug/kg body weight (Diet+BPA) vs. 4-day energy balance diet plus oral placebo consumption (Diet+No BPA). Forty participants will be randomized to Diet+BPA and Diet+No BPA and will reside in a supervised environment at Cal Poly's sleep research facilities for 6 days (2-day baseline run-in, followed by 4-day treatment). Main outcome measures (muscle insulin sensitivity and hepatic glucose suppression) will be assessed at baseline and treatment periods.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.
measure: Change in rate of glucose disposal
time frame: Baseline and 4 days
description: Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal
measure: Change in rate of glucose appearance
time frame: Baseline and 4 days
description: Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance
measure: Change in concentration of insulin
time frame: Baseline and 4 days
description: Fasting blood sample for insulin concentration
measure: Change in concentration of glucose
time frame: Baseline and 4 days
description: Fasting blood sample for glucose concentration
measure: Change in concentration of c-peptide
time frame: Baseline and 4 days
description: Fasting blood sample for c-peptide concentration
measure: Change in concentration of proinsulin
time frame: Baseline and 4 days
description: Fasting blood sample for proinsulin
measure: Change in concentration of adiponectin
time frame: Baseline and 4 days
description: Fasting blood sample for adiponectin
measure: Change in concentration of 17-beta estradiol
time frame: Baseline and 4 days
description: Fasting blood sample for 17-beta estradiol
measure: Change in concentration of firmicutes
time frame: Baseline and 4 days
description: Fecal microbiome concentration of firmicutes
measure: Change in concentration of clostridia
time frame: Baseline and 4 days
description: Fecal microbiome concentration of clostridia
arm group label: Diet plus bisphenol A
arm group type: Experimental
description: Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive a 4-day diet plus no bisphenol A.
intervention type: Behavioral
intervention name: bisphenol A
description: Vanilla wafer cookie with bisphenol A administered
arm group label: Diet plus bisphenol A
intervention type: Behavioral
intervention name: Placebo
description: Vanilla wafer cookie with no bisphenol A
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Todd Hagobian, PhD
role: Principal Investigator
affiliation: California Polytechnic State University-San Luis Obispo
last name: Hannah Brunner-Gaydos
role: Study Director
affiliation: California Polytechnic State University-San Luis Obispo
last name: Todd Hagobian, PhD
phone: 805-756-7511
email: thagobia@calpoly.edu
last name: Adam seal
phone: 805-756-5573
email: adseal@calpoly.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: California Polytechnic State University-San Luis Obispo
investigator full name: Todd Hagobian
investigator title: Associate Professor
mesh term: Congenital Microtia
mesh term: Insulin Resistance
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
mesh term: Hypersensitivity
mesh term: Bisphenol A
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 months of study completion, and will be available indefinitely.
ipd access criteria: Data access will be freely available for download on the Cal Poly Digital Commons website. Requestors will be required to sign a data access agreement.
ipd url: https://digitalcommons.calpoly.edu
provided document: 