<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/NCT01707979</url>
  </required_header>
  <id_info>
    <org_study_id>NIR</org_study_id>
    <nct_id>NCT01707979</nct_id>
  </id_info>
  <brief_title>NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes</brief_title>
  <acronym>NIR</acronym>
  <official_title>NIR (Near Infrared)- Spectroscopy and Multifrequent Impedance Spectroscopy on the Skin to Detection of Sensory and Autonomic Neuropathy Among Patients With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lise Tarnow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Steno Diabetes Center Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR&#xD;
      and impedance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using&#xD;
      NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of&#xD;
      diabetic neuropathy.&#xD;
&#xD;
      The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>near infrared spectroscopy</measure>
    <time_frame>one time</time_frame>
    <description>Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Diabetic Neuropathy</condition>
  <arm_group>
    <arm_group_label>Diabetic neuropathy</arm_group_label>
    <description>Male participants, type1 diabetic with diabetic neuropathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetes without neuropathy</arm_group_label>
    <description>Male participants, type1 diabetic without diabetic neuropathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non diabetic control</arm_group_label>
    <description>Male participants, control group non diabetic</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Control group men without diabetes Type1 diabetic men without neuropathy complications Type&#xD;
        1 diabetic men with neuropathy complications&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men with type 1 diabetes (WHO criteria)&#xD;
&#xD;
          -  age 35-50 years&#xD;
&#xD;
          -  duration of diabetes &gt; 10 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  P-creatinine&gt; 120 micromol/l&#xD;
&#xD;
          -  other acute or chronic disease, or type of treatment that makes the patient unsuitable&#xD;
             to participate, valuated by the investigator&#xD;
&#xD;
          -  non intact skin on the measuring spots&#xD;
&#xD;
          -  the patient is unable to understand the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lise Tarnow, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Steno Diabetes Center Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Steno Diabetes Center</name>
      <address>
        <city>Gentofte</city>
        <zip>2820</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Steno Diabetes Center Copenhagen</investigator_affiliation>
    <investigator_full_name>Lise Tarnow</investigator_full_name>
    <investigator_title>Professor, Chief Physician</investigator_title>
  </responsible_party>
  <keyword>Near infrared light</keyword>
  <keyword>Diabetic neuropathy</keyword>
  <keyword>Sensory neuropathy</keyword>
  <keyword>Autonomic neuropathy</keyword>
  <keyword>Vagus</keyword>
  <keyword>Sudomotor function</keyword>
  <keyword>Monofilament</keyword>
  <keyword>Impedance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Neuropathies</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/NCT01707979
org study id: NIR
nct id: NCT01707979
lead sponsor: 
has dmc: Yes
The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR
      and impedance.
The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using
      NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of
      diabetic neuropathy.

      The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.
observational model: Case-Control
time perspective: Cross-Sectional
measure: near infrared spectroscopy
time frame: one time
description: Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe
arm group label: Diabetic neuropathy
description: Male participants, type1 diabetic with diabetic neuropathy
arm group label: Diabetes without neuropathy
description: Male participants, type1 diabetic without diabetic neuropathy
arm group label: Non diabetic control
description: Male participants, control group non diabetic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lise Tarnow, Professor
role: Principal Investigator
affiliation: Steno Diabetes Center Copenhagen
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Steno Diabetes Center Copenhagen
investigator full name: Lise Tarnow
investigator title: Professor, Chief Physician
mesh term: Diabetic Neuropathies