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/NCT06041399</url>
    </required_header>
    <id_info>
      <org_study_id>Dbinbin</org_study_id>
      <nct_id>NCT06041399</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.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center(about five), randomized, double-blind, placebo-controlled clinical&#xD;
        trial with over 1000 subjects.Clinical data were collected by consulting the patient's&#xD;
        electronic history. The data included demographic information, blood biochemical markers and&#xD;
        electromyography. All participants provided their written informed consent to participate in&#xD;
        this study.The study protocol was approved by the Ethics Committee of the First Affiliated&#xD;
        Hospital of Wenzhou Medical 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>
    <phase>Phase 4</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the severity of diabetic peripheral neuropathy</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 diabetic peripheral neuropathy</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 diabetic peripheral neuropathy diagnosis by a specialist.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">1400</enrollment>
    <condition>Diabetic Peripheral Neuropathy</condition>
    <arm_group>
      <arm_group_label>diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs.</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs group.No hypoglycemic or lipid-lowering drugs were used in this group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diabetic group with hypoglycemic or lipid-lowering drugs.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group with hypoglycemic or lipid-lowering drugs group. group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diabetic group without hypoglycemic or lipid-lowering drugs.</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group without hypoglycemic or lipid-lowering drugs group.No hypoglycemic or lipid-lowering drugs were used in this group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>hypoglycemic Agents(metformin)</intervention_name>
      <description>patients treated with hypoglycemic Agents(metformin)</description>
      <arm_group_label>Diabetic group with hypoglycemic or lipid-lowering drugs.</arm_group_label>
      <arm_group_label>diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>lipid-lowering drug(Statin)</intervention_name>
      <description>patients treated with lipid-lowering drug(Statin)</description>
      <arm_group_label>Diabetic group with hypoglycemic or lipid-lowering drugs.</arm_group_label>
      <arm_group_label>diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients who had undergone nerve conduction examination by electromyography(EMG).&#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>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Binbin Deng, Doctor</last_name>
      <phone>86-13695720610</phone>
      <email>dbinbin@aliyun.com</email>
    </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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metformin</mesh_term>
      <mesh_term>Hypoglycemic Agents</mesh_term>
      <mesh_term>Hypolipidemic Agents</mesh_term>
    </intervention_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/NCT06041399
  org study id: Dbinbin
  nct id: NCT06041399
  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.
  This is a multi-center(about five), randomized, double-blind, placebo-controlled clinical
        trial 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).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  measure: the severity of diabetic peripheral neuropathy
  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 diabetic peripheral neuropathy
  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 diabetic peripheral neuropathy diagnosis by a specialist.
  arm group label: diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.
  arm group type: Experimental
  description: Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.
  arm group label: diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs.
  arm group type: No Intervention
  description: Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs group.No hypoglycemic or lipid-lowering drugs were used in this group.
  arm group label: Diabetic group with hypoglycemic or lipid-lowering drugs.
  arm group type: Experimental
  description: Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group with hypoglycemic or lipid-lowering drugs group. group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.
  arm group label: Diabetic group without hypoglycemic or lipid-lowering drugs.
  arm group type: No Intervention
  description: Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group without hypoglycemic or lipid-lowering drugs group.No hypoglycemic or lipid-lowering drugs were used in this group.
  intervention type: Drug
  intervention name: hypoglycemic Agents(metformin)
  description: patients treated with hypoglycemic Agents(metformin)
  arm group label: Diabetic group with hypoglycemic or lipid-lowering drugs.
  arm group label: diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.
  intervention type: Drug
  intervention name: lipid-lowering drug(Statin)
  description: patients treated with lipid-lowering drug(Statin)
  arm group label: Diabetic group with hypoglycemic or lipid-lowering drugs.
  arm group label: diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Binbin Deng, Doctor
  phone: 86-13695720610
  email: dbinbin@aliyun.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Peripheral Nervous System Diseases
  mesh term: Diabetic Neuropathies
  mesh term: Metformin
  mesh term: Hypoglycemic Agents
  mesh term: Hypolipidemic Agents