<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/NCT02216201</url>
  </required_header>
  <id_info>
    <org_study_id>Impeto-015</org_study_id>
    <nct_id>NCT02216201</nct_id>
  </id_info>
  <brief_title>Clinical Utility of SUDOSCAN in the Pediatric Population</brief_title>
  <official_title>Clinical Utility of SUDOSCAN in the Pediatric Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Impeto Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Impeto Medical</source>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical&#xD;
      device for the the determination of sweat gland function in the pediatric population.&#xD;
&#xD;
      Primary Objective: To measure sweat gland function in a pediatric population&#xD;
&#xD;
      Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland&#xD;
      function in the pediatric population&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor terminated study&#xD;
  </why_stopped>
  <start_date>December 2014</start_date>
  <primary_completion_date type="Anticipated">December 2015</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>Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Sweat gland function will be assessed within each age group&#xD;
Correlation with parameters associated with pre-diabetes and diabetes</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Prediabetes</condition>
  <condition>Diabetes</condition>
  <eligibility>
    <study_pop>
      <textblock>
        100 subjects will be recruited by age group, with approximately 10 subjects representative&#xD;
        of each age between 8 and 17. Both lean and obese subjects will be included from University&#xD;
        of Southern California's Childhood Obesity Research Center (CORC).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females ages 8 to 17 years&#xD;
&#xD;
          -  Able to give assent as well as parental consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 or type 2 diabetes&#xD;
&#xD;
          -  Chronic autoimmune condition&#xD;
&#xD;
          -  Taking chronic immunosuppressive or anti-inflammatory medications&#xD;
&#xD;
          -  Unable to apply palms of the hands and soles of the feet on the sensor plates during a&#xD;
             3 minute Sudoscan test&#xD;
&#xD;
          -  Presence of hepatitis B or C&#xD;
&#xD;
          -  Presence of HIV&#xD;
&#xD;
          -  Presence of known neurological disorder&#xD;
&#xD;
          -  Pregnancy and/or breastfeeding&#xD;
&#xD;
          -  Any open wound on the soles of the feet or palms of the hands&#xD;
&#xD;
          -  Participation in an ongoing clinical investigational drug trial&#xD;
&#xD;
          -  Other serious medical conditions that in the opinion of the investigator, would&#xD;
             compromise the subject's participation in the study&#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>
  <location>
    <facility>
      <name>University of Southern California's Childhood Obesity Research Center (CORC)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Muller G, Olschewski J, Stange T, Hjellset VT, Bornstein S, Schwarz PE. Non-invasive screening of diabetes risk by assessing abnormalities of sudomotor function. Exp Clin Endocrinol Diabetes. 2015 Jan;123(1):34-8. doi: 10.1055/s-0033-1357128. Epub 2014 May 5.</citation>
    <PMID>24798863</PMID>
  </reference>
  <reference>
    <citation>Muller G, Parfentyeva E, Olschewsky J, Bornstein SR, Schwarz PE. Assessment of small fiber neuropathy to predict future risk of type 2 diabetes. Prim Care Diabetes. 2013 Dec;7(4):269-73. doi: 10.1016/j.pcd.2013.08.001. Epub 2013 Sep 27.</citation>
    <PMID>24076379</PMID>
  </reference>
  <reference>
    <citation>Chen L, Chen X, Ding R, Shi Q Jr, Hu D. Evaluation of EZSCAN as a screening tool for impaired glucose metabolism. Diabetes Res Clin Pract. 2013 May;100(2):210-4. doi: 10.1016/j.diabres.2013.03.001. Epub 2013 Mar 22.</citation>
    <PMID>23529065</PMID>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>November 7, 2014</last_update_submitted>
  <last_update_submitted_qc>November 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</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/NCT02216201
org study id: Impeto-015
nct id: NCT02216201
lead sponsor: 
The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical
      device for the the determination of sweat gland function in the pediatric population.

      Primary Objective: To measure sweat gland function in a pediatric population

      Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland
      function in the pediatric population
observational model: Cohort
time perspective: Prospective
measure: Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores
time frame: Baseline
description: Sweat gland function will be assessed within each age group
Correlation with parameters associated with pre-diabetes and diabetes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Muller G, Olschewski J, Stange T, Hjellset VT, Bornstein S, Schwarz PE. Non-invasive screening of diabetes risk by assessing abnormalities of sudomotor function. Exp Clin Endocrinol Diabetes. 2015 Jan;123(1):34-8. doi: 10.1055/s-0033-1357128. Epub 2014 May 5.
PMID: 24798863
citation: Muller G, Parfentyeva E, Olschewsky J, Bornstein SR, Schwarz PE. Assessment of small fiber neuropathy to predict future risk of type 2 diabetes. Prim Care Diabetes. 2013 Dec;7(4):269-73. doi: 10.1016/j.pcd.2013.08.001. Epub 2013 Sep 27.
PMID: 24076379
citation: Chen L, Chen X, Ding R, Shi Q Jr, Hu D. Evaluation of EZSCAN as a screening tool for impaired glucose metabolism. Diabetes Res Clin Pract. 2013 May;100(2):210-4. doi: 10.1016/j.diabres.2013.03.001. Epub 2013 Mar 22.
PMID: 23529065
responsible party type: Sponsor
mesh term: Pediatric Obesity