<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/NCT03252132</url>
  </required_header>
  <id_info>
    <org_study_id>IDNC-DD2-MUSCLE</org_study_id>
    <nct_id>NCT03252132</nct_id>
  </id_info>
  <brief_title>Resistance Training in Patients With Diabetic Neuropathy</brief_title>
  <official_title>Resistance Training in Patients With Diabetic Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Pain Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Danish Pain Research Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a population-based study of type 2 diabetes patients with and without neuropathy&#xD;
      recruited from the Danish National Type 2 Diabetes cohort (DD2).&#xD;
&#xD;
      Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain,&#xD;
      muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural&#xD;
      instability increasing the risk of frequent falls and thereby increased morbidity and&#xD;
      mortality. Thus, diabetic neuropathy is associated with significant disabilities having major&#xD;
      impact on activities of daily living and quality of life.&#xD;
&#xD;
      The effects of resistance training on neuropathy symptoms, muscle strength and muscle&#xD;
      structure in patients with and with diabetic neuropathy will be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perspective: The studies will likely improve the understanding of diabetic neuropathy and the&#xD;
      relation between risk of falls in patients with and without motor dysfunction. The results&#xD;
      may enable new and more precise recommendations for exercise in diabetic patients with&#xD;
      diabetic neuropathy. In addition, the results may lead to a better understanding of the&#xD;
      mechanisms underlying the effects of training. The improvement of motor function may lead to&#xD;
      improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes&#xD;
      patients, resulting in lower morbidity and mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>
    <intervention_model_description>International, randomized controlled training trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraepidermal nerve fiber density (IENFD)</measure>
    <time_frame>Change from baseline IENFD at 12 weeks</time_frame>
    <description>1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength (isokinetic strength)</measure>
    <time_frame>Change from baseline IENFD at 12 weeks</time_frame>
    <description>Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Polyneuropathy Diabetes</condition>
  <condition>Diabetes Complications</condition>
  <condition>Diabetic Peripheral Neuropathy</condition>
  <condition>Muscle Weakness</condition>
  <condition>Fall Patients</condition>
  <arm_group>
    <arm_group_label>12-week resistance training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>12-week resistance training</intervention_name>
    <description>Training will consist of a minimum of 5 supervised training sessions every 2 weeks and each session will be approximately 60 minutes in duration. Patients will be performing resistance training consisting of at least 3 exercises affecting the largest muscle groups of the body, training the most basic movement patterns that work the entire body as a coordinated system. Patients will train according to a linear progressive model with a slow increase in weight every training session focusing on the flexors, extensors of the ankle and knee and on flexors, extensors and abductors of the hip.</description>
    <arm_group_label>12-week resistance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of type 2 diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuropathy due to any other cause&#xD;
&#xD;
               -  BMI &gt;40&#xD;
&#xD;
               -  Pacemaker&#xD;
&#xD;
               -  Comorbidity that contraindicates exercise&#xD;
&#xD;
               -  History of stroke with affection of the lower extremities&#xD;
&#xD;
               -  Ischemic heart disease&#xD;
&#xD;
               -  Any other neurological disease&#xD;
&#xD;
               -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karolina Snopek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Pain Research Center, Aarhus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danish Pain Research Center, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</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>Muscle Weakness</mesh_term>
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Neuropathies</mesh_term>
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Diabetes Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03252132
org study id: IDNC-DD2-MUSCLE
nct id: NCT03252132
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a population-based study of type 2 diabetes patients with and without neuropathy
      recruited from the Danish National Type 2 Diabetes cohort (DD2).

      Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain,
      muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural
      instability increasing the risk of frequent falls and thereby increased morbidity and
      mortality. Thus, diabetic neuropathy is associated with significant disabilities having major
      impact on activities of daily living and quality of life.

      The effects of resistance training on neuropathy symptoms, muscle strength and muscle
      structure in patients with and with diabetic neuropathy will be examined.
Perspective: The studies will likely improve the understanding of diabetic neuropathy and the
      relation between risk of falls in patients with and without motor dysfunction. The results
      may enable new and more precise recommendations for exercise in diabetic patients with
      diabetic neuropathy. In addition, the results may lead to a better understanding of the
      mechanisms underlying the effects of training. The improvement of motor function may lead to
      improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes
      patients, resulting in lower morbidity and mortality.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: International, randomized controlled training trial
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Intraepidermal nerve fiber density (IENFD)
time frame: Change from baseline IENFD at 12 weeks
description: 1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function.
measure: Muscle strength (isokinetic strength)
time frame: Change from baseline IENFD at 12 weeks
description: Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle.
arm group label: 12-week resistance training
arm group type: Active Comparator
arm group label: No training
arm group type: No Intervention
intervention type: Other
intervention name: 12-week resistance training
description: Training will consist of a minimum of 5 supervised training sessions every 2 weeks and each session will be approximately 60 minutes in duration. Patients will be performing resistance training consisting of at least 3 exercises affecting the largest muscle groups of the body, training the most basic movement patterns that work the entire body as a coordinated system. Patients will train according to a linear progressive model with a slow increase in weight every training session focusing on the flexors, extensors of the ankle and knee and on flexors, extensors and abductors of the hip.
arm group label: 12-week resistance training
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karolina Snopek, MD
role: Principal Investigator
affiliation: Danish Pain Research Center, Aarhus University
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Muscle Weakness
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies
mesh term: Polyneuropathies
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Complications
sharing ipd: No