<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/NCT02218866</url>
  </required_header>
  <id_info>
    <org_study_id>BAR-UofU</org_study_id>
    <nct_id>NCT02218866</nct_id>
  </id_info>
  <brief_title>The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration</brief_title>
  <acronym>BAR</acronym>
  <official_title>The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is understand if obesity is a major factor for neuropathy&#xD;
      development in patients with and without Type 2 diabetes. This study will examine the&#xD;
      relationship between weight, metabolism, and nerve function and regeneration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral neuropathy causes progressive injury to the longest nerves of the body, starting&#xD;
      in the toes, then progressing slowly up the leg. Neuropathy often causes pain, numbness, and&#xD;
      weakness if the feet and can lead to reduced mobility, foot ulcers, and even amputation. The&#xD;
      most common cause is diabetes, but work at the University of Utah finds that prediabetes and&#xD;
      other consequences of obesity, including abnormal cholesterol levels, may be associated with&#xD;
      neuropathy. Research has shown that these risk factors may damage nerves and interfere with&#xD;
      the ability of nerves to grow back after an injury.&#xD;
&#xD;
      This study aims to&#xD;
&#xD;
        1. characterize peripheral nerve function and cutaneous nerve structure in obese bariatric&#xD;
           surgery candidates;&#xD;
&#xD;
        2. evaluate peripheral nerve regeneration capacity (and other nerve function measures)&#xD;
           before and after bariatric surgery in obese subjects with no or mild neuropathy;&#xD;
&#xD;
        3. examine the relationship between ectopic lipid accumulation, lipotoxic mediators,&#xD;
           neuropathy and regeneration capacity in surgical candidates before and one year after&#xD;
           surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in reinnervation capacity</measure>
    <time_frame>4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Utah Early Neuropathy Scale (UENS)</measure>
    <time_frame>Baseline to 12 months after bariatric surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Nerve Conduction Study measures</measure>
    <time_frame>Baseline to 12 months after bariatric surgery</time_frame>
    <description>Nerve Conduction Study is a procedure routinely used in the diagnosis of neuropathy. Measures will include Sural sensory and Peroneal motor amplitudes and conduction velocities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nerve fiber density</measure>
    <time_frame>Baseline to 12 months after bariatric surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">205</enrollment>
  <condition>Peripheral Neuropathy</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>All participants will be examined by a neurologist to test sensation, reflexes, and strength and complete a few questionnaires. Tests will be performed to measure nerve function and small punch skin biopsies will be taken to assess nerve fiber density. Blood and urine tests will measure various markers of interest. Participants will be seen before and after their bariatric surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>In addition to the procedures described for Group 1, participants in Group 2 will have the following procedures:&#xD;
During bariatric surgery, a small biopsy from the liver and abdominal fat will be taken to examine how fat is processed within the body.&#xD;
At the first visit, after a skin biopsy is taken, a small capsaicin patch will be placed on the lower thigh. The patch will remain in place for 48 hours and will cause the nerves in the immediate area to pull back from the skin. A biopsy will be taken from the patch area 48 hours, 1 month, and 3 months after the initial biopsy. This procedure will be repeated after surgery.&#xD;
MRIs may be performed before and after bariatic surgery.&#xD;
Participants may be asked to complete additional tests to evaluate nerve function</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Group 3 will comprise of individuals who are not overweight. Participants in this group will undergo a similar evaluation to Group 2.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA, serum, tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited through bariatric surgery clinics in the local area.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80 years old&#xD;
&#xD;
          -  Subjects must fulfill criteria for bariatric surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of foot ulceration or neurogenic arthropathy&#xD;
&#xD;
          -  Family history of non-diabetic neuropathy in a first-degree family member.&#xD;
&#xD;
          -  Presence of any disease known to be associated with peripheral neuropathy including&#xD;
             but not limited to vitamin deficiency, toxin exposure, paraproteinemia, heavy alcohol&#xD;
             use, hepatitis C, HIV.&#xD;
&#xD;
          -  Coumadin use.&#xD;
&#xD;
          -  Inability to understand or cooperate with the procedures of the trial.&#xD;
&#xD;
          -  Known history of sensitivity to capsaicin products.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>A. Gordon Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>April 8, 2018</last_update_submitted>
  <last_update_submitted_qc>April 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Gordon Smith</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Bariatric surgery</keyword>
  <keyword>Obesity</keyword>
  <keyword>Neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</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/NCT02218866
org study id: BAR-UofU
nct id: NCT02218866
lead sponsor: 
collaborator: 
has dmc: No
The goal of this research is understand if obesity is a major factor for neuropathy
      development in patients with and without Type 2 diabetes. This study will examine the
      relationship between weight, metabolism, and nerve function and regeneration.
Peripheral neuropathy causes progressive injury to the longest nerves of the body, starting
      in the toes, then progressing slowly up the leg. Neuropathy often causes pain, numbness, and
      weakness if the feet and can lead to reduced mobility, foot ulcers, and even amputation. The
      most common cause is diabetes, but work at the University of Utah finds that prediabetes and
      other consequences of obesity, including abnormal cholesterol levels, may be associated with
      neuropathy. Research has shown that these risk factors may damage nerves and interfere with
      the ability of nerves to grow back after an injury.

      This study aims to

        1. characterize peripheral nerve function and cutaneous nerve structure in obese bariatric
           surgery candidates;

        2. evaluate peripheral nerve regeneration capacity (and other nerve function measures)
           before and after bariatric surgery in obese subjects with no or mild neuropathy;

        3. examine the relationship between ectopic lipid accumulation, lipotoxic mediators,
           neuropathy and regeneration capacity in surgical candidates before and one year after
           surgery.
observational model: Case-Control
time perspective: Prospective
measure: Change in reinnervation capacity
time frame: 4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery
measure: Change in Utah Early Neuropathy Scale (UENS)
time frame: Baseline to 12 months after bariatric surgery
measure: Change in Nerve Conduction Study measures
time frame: Baseline to 12 months after bariatric surgery
description: Nerve Conduction Study is a procedure routinely used in the diagnosis of neuropathy. Measures will include Sural sensory and Peroneal motor amplitudes and conduction velocities.
measure: Change in nerve fiber density
time frame: Baseline to 12 months after bariatric surgery
arm group label: Group 1
description: All participants will be examined by a neurologist to test sensation, reflexes, and strength and complete a few questionnaires. Tests will be performed to measure nerve function and small punch skin biopsies will be taken to assess nerve fiber density. Blood and urine tests will measure various markers of interest. Participants will be seen before and after their bariatric surgery.
arm group label: Group 2
description: In addition to the procedures described for Group 1, participants in Group 2 will have the following procedures:
During bariatric surgery, a small biopsy from the liver and abdominal fat will be taken to examine how fat is processed within the body.
At the first visit, after a skin biopsy is taken, a small capsaicin patch will be placed on the lower thigh. The patch will remain in place for 48 hours and will cause the nerves in the immediate area to pull back from the skin. A biopsy will be taken from the patch area 48 hours, 1 month, and 3 months after the initial biopsy. This procedure will be repeated after surgery.
MRIs may be performed before and after bariatic surgery.
Participants may be asked to complete additional tests to evaluate nerve function
arm group label: Group 3
description: Group 3 will comprise of individuals who are not overweight. Participants in this group will undergo a similar evaluation to Group 2.
DNA, serum, tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: A. Gordon Smith, MD
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Gordon Smith
investigator title: Professor
mesh term: Peripheral Nervous System Diseases