xml: <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/NCT06041412</url>
    </required_header>
    <id_info>
      <org_study_id>DPN</org_study_id>
      <nct_id>NCT06041412</nct_id>
    </id_info>
    <brief_title>The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy</brief_title>
    <official_title>The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital of Wenzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Wenzhou Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to explore the relationship between related blood&#xD;
        indicators and diabetic peripheral neuropathy(DPN).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multicenter study(approximately four) with over 1000 subjects.Clinical data were&#xD;
        collected by consulting the patient's electronic history. The data included demographic&#xD;
        information, blood biochemical markers and electromyography. All participants provided their&#xD;
        written informed consent to participate in this study.The study protocol was approved by the&#xD;
        Ethics Committee of the First Affiliated Hospital of Wenzhou Medical&#xD;
        University(KY-2022-R009).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2012</start_date>
    <completion_date type="Anticipated">January 2, 2025</completion_date>
    <primary_completion_date type="Actual">December 18, 2022</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the severity of DPN</measure>
      <time_frame>From admission to discharge, up to 1 week</time_frame>
      <description>The nerve conduction examination was conducted at a room temperature of 24℃, with the legs warmed using an electric heating pad for at least 10 minutes to achieve a skin temperature of 32-35℃. The nerve conduction velocities and nerve conduction amplitudes were measured for both sides of the upper and lower limbs, including motor and sensory branches of the median nerve; motor and sensory branches of the ulnar nerve; motor branch of peroneal nerve; motor branch of the tibial nerve; sensory branch of the superficial peroneal nerve. In addition, both sides of the tibial nerve F-wave were recorded, and the lower one was regarded as the final F-wave. Slowed/blocked nerve conduction was defined as more than 2.5 standard deviation below the control nerve conduction threshold. Nerve conduction is defined as abnormal when two or more nerve abnormalities are detected.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the presence of DPN</measure>
      <time_frame>From admission to discharge, up to 1 week</time_frame>
      <description>When any of the elements of the screening process -- symptoms, signs, or abnormal nerve conduction parameters --was abnormal, medical records would be scrutinized to see if these participants had accepted a previous DPN diagnosis by a specialist.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">1400</enrollment>
    <condition>Diabetic Peripheral Neuropathy</condition>
    <arm_group>
      <arm_group_label>DPN group</arm_group_label>
      <description>Patients with type 2 diabetic peripheral neuropathy were categorized into the DPN group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diabetic group</arm_group_label>
      <description>patients with type 2 diabetes mellitus but not with DPN were distributed into the Diabetic group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>The other individuals without type 2 diabetes mellitus were selected as the control group</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This is a multicenter study(approximately four) with over 1000 subjects.Clinical data were&#xD;
          collected by consulting the patient's electronic history. The data included demographic&#xD;
          information, blood biochemical markers and electromyography. All participants provided&#xD;
          their written informed consent to participate in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients who had undergone nerve conduction examination by electromyography.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant&#xD;
               diseases, severe respiratory diseases, heart failure, and acute infections;&#xD;
  &#xD;
            -  patients with alcohol abuse; history of Autoimmune liver disease, liver disease or&#xD;
               abnormal liver function at baseline;&#xD;
  &#xD;
            -  parathyroid diseases (including hyperthyroidism and hypothyroidism);&#xD;
  &#xD;
            -  pancreatitis, pancreatectomy or any transplant;&#xD;
  &#xD;
            -  patients with malignancy and any serious concomitant disease limit the existence of&#xD;
               life expectancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Binbin Deng</last_name>
      <phone>dbinbin@aliyun.com</phone>
    </overall_contact>
    <location>
      <facility>
        <name>First Affiliated Hospital of Wenzhou Medical University</name>
        <address>
          <city>Wenzhou</city>
          <state>Zhejiang</state>
          <zip>325000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Binbin Deng, Doctor</last_name>
        <phone>+8613695720610</phone>
        <email>dbinbin@aliyun.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>December 26, 2022</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Diabetic Peripheral Neuropathy</keyword>
    <keyword>electromyography</keyword>
    <keyword>blood parameters</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
      <mesh_term>Diabetic Neuropathies</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041412
  org study id: DPN
  nct id: NCT06041412
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to explore the relationship between related blood
        indicators and diabetic peripheral neuropathy(DPN).
  This is a multicenter study(approximately four) with over 1000 subjects.Clinical data were
        collected by consulting the patient's electronic history. The data included demographic
        information, blood biochemical markers and electromyography. All participants provided their
        written informed consent to participate in this study.The study protocol was approved by the
        Ethics Committee of the First Affiliated Hospital of Wenzhou Medical
        University(KY-2022-R009).
  observational model: Case-Control
  time perspective: Retrospective
  measure: the severity of DPN
  time frame: From admission to discharge, up to 1 week
  description: The nerve conduction examination was conducted at a room temperature of 24℃, with the legs warmed using an electric heating pad for at least 10 minutes to achieve a skin temperature of 32-35℃. The nerve conduction velocities and nerve conduction amplitudes were measured for both sides of the upper and lower limbs, including motor and sensory branches of the median nerve; motor and sensory branches of the ulnar nerve; motor branch of peroneal nerve; motor branch of the tibial nerve; sensory branch of the superficial peroneal nerve. In addition, both sides of the tibial nerve F-wave were recorded, and the lower one was regarded as the final F-wave. Slowed/blocked nerve conduction was defined as more than 2.5 standard deviation below the control nerve conduction threshold. Nerve conduction is defined as abnormal when two or more nerve abnormalities are detected.
  measure: the presence of DPN
  time frame: From admission to discharge, up to 1 week
  description: When any of the elements of the screening process -- symptoms, signs, or abnormal nerve conduction parameters --was abnormal, medical records would be scrutinized to see if these participants had accepted a previous DPN diagnosis by a specialist.
  arm group label: DPN group
  description: Patients with type 2 diabetic peripheral neuropathy were categorized into the DPN group
  arm group label: Diabetic group
  description: patients with type 2 diabetes mellitus but not with DPN were distributed into the Diabetic group.
  arm group label: control group
  description: The other individuals without type 2 diabetes mellitus were selected as the control group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Binbin Deng
  phone: dbinbin@aliyun.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Peripheral Nervous System Diseases
  mesh term: Diabetic Neuropathies