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/NCT06033508</url>
    </required_header>
    <id_info>
      <org_study_id>E-60116787-020-338517</org_study_id>
      <nct_id>NCT06033508</nct_id>
    </id_info>
    <brief_title>Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients With and Without Polyneuropathy</brief_title>
    <official_title>Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients With and Without Polyneuropathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pamukkale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pamukkale University</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>
        The aim of this study is to show how whole body vibration training practiced for 12 weeks&#xD;
        affects the levels of inflammatory biomarkers such as C reactive protein (CRP), interleukin-6&#xD;
        (IL-6), interleukin -10 (IL_10), in Type 2 diabetic patients (T2DM) with and without&#xD;
        peripheral neuropathy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Volunteers with type 2 diabetes mellitus with and without peripheric neuropathy will be&#xD;
        evaluated in terms of any contra-indication that will restrain them from making exercise with&#xD;
        whole body vibration device. 90 male or female volunteers who are suitable in terms of&#xD;
        inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly&#xD;
        distributed to one of the 3 groups. Each group will contain 30 participants. 1st group and&#xD;
        3rd group will include type 2 diabetic patients with peripheric neuropathy and 2nd group will&#xD;
        include type 2 diabetic patients without neuropathy. Patients in group 1 and 2 will make&#xD;
        static isometric exercises on vibration platform whereas patients in group 3 will make the&#xD;
        same exercises on land in the hospital setting. Participants will be requested to complete 3&#xD;
        months of exercise. They will be evaluated before and at the end of the 3 months of exercise&#xD;
        with physical measures such as waist and hip circumference, 6-minute walk test, body&#xD;
        composition measured by bioimpedance, muscle thickness, and blood tests to measure&#xD;
        inflammatory biomarkers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <phase>N/A</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>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>inflammatory markers</measure>
      <time_frame>12 weeks</time_frame>
      <description>level of CRP</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Type 2 Diabetes</condition>
    <condition>Diabetic Peripheral Neuropathy</condition>
    <condition>Exercise</condition>
    <arm_group>
      <arm_group_label>T2DM with neuropathy + WBV</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration</description>
    </arm_group>
    <arm_group>
      <arm_group_label>T2DM without neuropathy + WBV</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients without type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration</description>
    </arm_group>
    <arm_group>
      <arm_group_label>T2DM with neuropathy + land exercise</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients with type 2 Diabetes mellitus with neuropathy who will be trained on land</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise with whole body vibration device</intervention_name>
      <description>exercise with whole body vibration device</description>
      <arm_group_label>T2DM with neuropathy + WBV</arm_group_label>
      <arm_group_label>T2DM without neuropathy + WBV</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>placebo exercise</intervention_name>
      <description>exercise without vibration on land</description>
      <arm_group_label>T2DM with neuropathy + land exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants must stand and walk o without using an assistive device.&#xD;
  &#xD;
            2. Participants must have HbA1C level below 8.5&#xD;
  &#xD;
            3. Participants must have a weight of less than 120 kg.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. T2DM patients with advanced cardiovascular, renal, hepatic disease&#xD;
  &#xD;
            2. T2DM patients with diabetic retinopathy or nephropathy&#xD;
  &#xD;
            3. T2DM patients with untreated hypertension, rhythm disorders, and those who have&#xD;
               undergone bypass surgery&#xD;
  &#xD;
            4. T2DM patients with ischemic changes in the resting ECG&#xD;
  &#xD;
            5. T2DM patients with untreated hypoglycemia or orthostatic hypotension&#xD;
  &#xD;
            6. T2DM patients who are unable to walk independently, or use of canes, crutches or&#xD;
               wheelchairs&#xD;
  &#xD;
            7. T2DM patients who have open ulcers or wounds on load-bearing surfaces&#xD;
  &#xD;
            8. T2DM patients with inflammatory rheumatic diseases such as rheumatoid arthritis&#xD;
  &#xD;
            9. T2DM patients with active infectious disease&#xD;
  &#xD;
           10. T2DM patients with high risk of thrombosis, those with deep vein thrombosis&#xD;
  &#xD;
           11. T2DM patients who carry a pacemaker, prosthesis, intrauterine device or metal implant,&#xD;
  &#xD;
           12. T2DM patients with a history of cancer&#xD;
  &#xD;
           13. T2DM patients with severe migraine, epilepsy, stroke or other neurological disorders,&#xD;
               those who have undergone brain surgery&#xD;
  &#xD;
           14. T2DM patients with non-diabetic neuropathy due to reasons such as HIV, AIDS, alcohol,&#xD;
               uremia&#xD;
  &#xD;
           15. T2DM patients with cognitive impairment&#xD;
  &#xD;
           16. T2DM patients who are on psychotropic or neurotoxic therapy&#xD;
  &#xD;
           17. T2DM patients with advanced balance problems&#xD;
  &#xD;
           18. T2DM patients who are pregnant or breastfeeding mothers&#xD;
  &#xD;
           19. T2DM patients who are organ transplant recipients&#xD;
  &#xD;
           20. T2DM patients with hernia&#xD;
  &#xD;
           21. T2DM patients with kidney or bladder stones&#xD;
  &#xD;
           22. T2DM patients who are exposed to mechanical vibration due to their job&#xD;
  &#xD;
           23. T2DM patients who received insulin therapy during their participation in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>GULIN FINDIKOGLU, Assoc Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pamukkale University, Medical Faculty, PMR Department</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>GULIN FINDIKOGLU, MD PhD</last_name>
      <phone>90 258 2966000</phone>
      <phone_ext>4956</phone_ext>
      <email>gulin_dr@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fulden Ozturk, MD</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pamukkale University</name>
        <address>
          <city>Denizli</city>
          <zip>21600</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pamukkale University</investigator_affiliation>
      <investigator_full_name>GULIN FINDIKOGLU</investigator_full_name>
      <investigator_title>Assoc Prof Dr</investigator_title>
    </responsible_party>
    <keyword>Type 2 diabetes mellitus</keyword>
    <keyword>Diabetic Peripheral Neuropathy</keyword>
    <keyword>whole body vibration</keyword>
    <keyword>inflammation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
      <mesh_term>Polyneuropathies</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06033508
  org study id: E-60116787-020-338517
  nct id: NCT06033508
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to show how whole body vibration training practiced for 12 weeks
        affects the levels of inflammatory biomarkers such as C reactive protein (CRP), interleukin-6
        (IL-6), interleukin -10 (IL_10), in Type 2 diabetic patients (T2DM) with and without
        peripheral neuropathy.
  Volunteers with type 2 diabetes mellitus with and without peripheric neuropathy will be
        evaluated in terms of any contra-indication that will restrain them from making exercise with
        whole body vibration device. 90 male or female volunteers who are suitable in terms of
        inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly
        distributed to one of the 3 groups. Each group will contain 30 participants. 1st group and
        3rd group will include type 2 diabetic patients with peripheric neuropathy and 2nd group will
        include type 2 diabetic patients without neuropathy. Patients in group 1 and 2 will make
        static isometric exercises on vibration platform whereas patients in group 3 will make the
        same exercises on land in the hospital setting. Participants will be requested to complete 3
        months of exercise. They will be evaluated before and at the end of the 3 months of exercise
        with physical measures such as waist and hip circumference, 6-minute walk test, body
        composition measured by bioimpedance, muscle thickness, and blood tests to measure
        inflammatory biomarkers.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  measure: inflammatory markers
  time frame: 12 weeks
  description: level of CRP
  arm group label: T2DM with neuropathy + WBV
  arm group type: Active Comparator
  description: Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration
  arm group label: T2DM without neuropathy + WBV
  arm group type: Active Comparator
  description: Patients without type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration
  arm group label: T2DM with neuropathy + land exercise
  arm group type: Placebo Comparator
  description: Patients with type 2 Diabetes mellitus with neuropathy who will be trained on land
  intervention type: Other
  intervention name: exercise with whole body vibration device
  description: exercise with whole body vibration device
  arm group label: T2DM with neuropathy + WBV
  arm group label: T2DM without neuropathy + WBV
  intervention type: Other
  intervention name: placebo exercise
  description: exercise without vibration on land
  arm group label: T2DM with neuropathy + land exercise
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: GULIN FINDIKOGLU, Assoc Prof
  role: Principal Investigator
  affiliation: Pamukkale University, Medical Faculty, PMR Department
  last name: GULIN FINDIKOGLU, MD PhD
  phone: 90 258 2966000
  phone ext: 4956
  email: gulin_dr@yahoo.com
  last name: Fulden Ozturk, MD
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Pamukkale University
  investigator full name: GULIN FINDIKOGLU
  investigator title: Assoc Prof Dr
  mesh term: Peripheral Nervous System Diseases
  mesh term: Polyneuropathies
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No