<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/NCT03043235</url>
  </required_header>
  <id_info>
    <org_study_id>2237</org_study_id>
    <nct_id>NCT03043235</nct_id>
  </id_info>
  <brief_title>Race Adiposity Interactions Regulate Mechanisms Determining Insulin Sensitivity</brief_title>
  <official_title>Race Adiposity Interactions Regulate Mechanisms Determining Insulin Sensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</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 research study will examine how ethnic/racial background, body composition (%body fat),&#xD;
      and the location of body fat affect the ability of the hormone insulin to promote uptake of&#xD;
      blood sugar in persons who are 19 to 45 years of age. When insulin is ineffective in&#xD;
      promoting blood sugar uptake, this condition is termed &quot;insulin resistance.&quot; Insulin&#xD;
      resistance plays a major role in the development of chronic metabolic diseases (such as type&#xD;
      2 diabetes, cardiovascular disease, and cancer), many of which differ with race. Previous&#xD;
      studies suggest that insulin resistance is higher in African-Americans (AA) vs.&#xD;
      European-Americans (EA). However, results from these studies remain unclear due to different&#xD;
      testing measures used for insulin resistance as well as differences in body fat between&#xD;
      individuals. Results from this research study may help explain why insulin resistance differs&#xD;
      with genetic background and may guide development of personalized treatment strategies with&#xD;
      implications for several chronic metabolic diseases (e.g., type 2 diabetes, cardiovascular&#xD;
      disease, and cancer).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insulin resistance plays a major role in the etiology of chronic metabolic diseases, many of&#xD;
      which differ with race/ethnicity. Previous studies using mainly indirect methods suggest that&#xD;
      insulin sensitivity is lower in AA vs. EA. Our preliminary data using the reference standard&#xD;
      glucose clamp indicate that in lean individuals, insulin sensitivity is lower among AA, while&#xD;
      in obese individuals, insulin sensitivity is higher among AA. We hypothesize that this&#xD;
      race/body mass index (BMI) interaction may be explained in part by significantly lower&#xD;
      visceral and hepatic fat accumulation in AA. Conversely, based on our preliminary data, we&#xD;
      hypothesize that inherently greater oxidative stress impairs insulin sensitivity even in AA,&#xD;
      explaining lower insulin sensitivity in lean AA vs. EA. We propose to test these hypotheses&#xD;
      by prospectively comparing skeletal muscle and hepatic insulin sensitivity in healthy lean,&#xD;
      overweight, and obese AA and EA using the hyperinsulinemic isoglycemic glucose clamp.&#xD;
      Analysis of ancestral genes will permit simultaneous assessment of the contribution of&#xD;
      ancestry to main outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2014</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hyperinsulinemic isoglycemic glucose clamp</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">126</enrollment>
  <condition>Insulin Sensitivity</condition>
  <condition>Fat; Liver</condition>
  <arm_group>
    <arm_group_label>African American Females</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>African American Males</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caucasian Females</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caucasian Males</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA will be used to identify ancestry. This information is needed to understand why African&#xD;
      Americans and Caucasians have different risks for developing certain diseases.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        African American and Caucasian Males and Females between 19-45 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  African American or Caucasian&#xD;
&#xD;
          -  Body Mass Index 19-45&#xD;
&#xD;
          -  Do NOT have diabetes&#xD;
&#xD;
          -  Exercise less than 2 hours per week&#xD;
&#xD;
          -  Are willing to travel to UAB for 2 screens and 4 testing visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Any major medical conditions or medications that interfere with study outcomes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara Gower, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>July 12, 2018</last_update_submitted>
  <last_update_submitted_qc>July 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Barbara Gower</investigator_full_name>
    <investigator_title>Prinicipal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT03043235
org study id: 2237
nct id: NCT03043235
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study will examine how ethnic/racial background, body composition (%body fat),
      and the location of body fat affect the ability of the hormone insulin to promote uptake of
      blood sugar in persons who are 19 to 45 years of age. When insulin is ineffective in
      promoting blood sugar uptake, this condition is termed "insulin resistance." Insulin
      resistance plays a major role in the development of chronic metabolic diseases (such as type
      2 diabetes, cardiovascular disease, and cancer), many of which differ with race. Previous
      studies suggest that insulin resistance is higher in African-Americans (AA) vs.
      European-Americans (EA). However, results from these studies remain unclear due to different
      testing measures used for insulin resistance as well as differences in body fat between
      individuals. Results from this research study may help explain why insulin resistance differs
      with genetic background and may guide development of personalized treatment strategies with
      implications for several chronic metabolic diseases (e.g., type 2 diabetes, cardiovascular
      disease, and cancer).
Insulin resistance plays a major role in the etiology of chronic metabolic diseases, many of
      which differ with race/ethnicity. Previous studies using mainly indirect methods suggest that
      insulin sensitivity is lower in AA vs. EA. Our preliminary data using the reference standard
      glucose clamp indicate that in lean individuals, insulin sensitivity is lower among AA, while
      in obese individuals, insulin sensitivity is higher among AA. We hypothesize that this
      race/body mass index (BMI) interaction may be explained in part by significantly lower
      visceral and hepatic fat accumulation in AA. Conversely, based on our preliminary data, we
      hypothesize that inherently greater oxidative stress impairs insulin sensitivity even in AA,
      explaining lower insulin sensitivity in lean AA vs. EA. We propose to test these hypotheses
      by prospectively comparing skeletal muscle and hepatic insulin sensitivity in healthy lean,
      overweight, and obese AA and EA using the hyperinsulinemic isoglycemic glucose clamp.
      Analysis of ancestral genes will permit simultaneous assessment of the contribution of
      ancestry to main outcomes.
observational model: Case-Control
time perspective: Prospective
measure: Hyperinsulinemic isoglycemic glucose clamp
time frame: 5 years
arm group label: African American Females
description: No intervention
arm group label: African American Males
description: No intervention
arm group label: Caucasian Females
description: No intervention
arm group label: Caucasian Males
description: No intervention
DNA will be used to identify ancestry. This information is needed to understand why African
      Americans and Caucasians have different risks for developing certain diseases.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara Gower, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Barbara Gower
investigator title: Prinicipal Investigator
mesh term: Insulin Resistance
mesh term: Hypersensitivity
sharing ipd: No