<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/NCT01676883</url>
  </required_header>
  <id_info>
    <org_study_id>2012/1018</org_study_id>
    <nct_id>NCT01676883</nct_id>
  </id_info>
  <brief_title>Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons</brief_title>
  <official_title>Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have confirmed the association between plantar callosities and severely obese&#xD;
      individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for&#xD;
      estimating body composition because it is easy to use, noninvasive, relatively inexpensive,&#xD;
      and can be performed across a wide range of subjects.&#xD;
&#xD;
      Our hypotheses for this study are: (1)plantar callosities influence the body composition&#xD;
      measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the&#xD;
      percentage of body fat compared with air-displacement plethysmography (BodPod).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the prevalence of obesity continues to increase, many parts of the world are progressively&#xD;
      facing a rise in the number of people who fall under WHO obesity class 2 and 3. Since severe&#xD;
      obesity is characterized by large alterations in body compartments when compared to&#xD;
      overweight or non-obese individuals, there is a need for the evaluation of the body&#xD;
      composition of severely obese persons. There is very few published research available on what&#xD;
      methods of body composition measurements can be used on this population.&#xD;
&#xD;
      Other studies have also shown the tendency of bioelectrical impedance analysis (BIA)&#xD;
      instruments to underestimate percentage of fat mass and overestimate the percentage of fat&#xD;
      free nass, compared with gold-standard techniques. We think that plantar callosities might&#xD;
      have contributed to the lack of accurate measurements. Thus, the primary aim of this study is&#xD;
      to determine whether plantar callosities influence the validity of body composition&#xD;
      measurements obtained by BIA, using the InBody 720. The secondary aim is to assess the&#xD;
      validity of the body composition measurements obtained by BIA (InBody 720) in severely obese&#xD;
      individuals, using air-displacement plethysmography (BodPod) as the gold standard.&#xD;
      Additionally, we will explore various sources of error using test-retest reliabilities by&#xD;
      measuring body composition with different arm postures. We will examine this further to rule&#xD;
      out the possibility of &quot;positions of measurement&quot; as a potential confounder of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>1 day</time_frame>
    <description>Bioelectric impedance (using InBody 720) at three standardized arm postures angled at 15, 45 and 90 degrees, in randomized order; Air displacement plethysmography (ADP,using BodPod)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>body composition assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bioelectric impedance measurement pre- and post removal of calluses and corns (pedicure), then air-displacement plethysmography (gold standard)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bioelectric impedance</intervention_name>
    <description>removal of calluses and corns by pedicure</description>
    <arm_group_label>body composition assessment</arm_group_label>
    <other_name>BIA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air displacement plethysmography</intervention_name>
    <arm_group_label>body composition assessment</arm_group_label>
    <other_name>ADP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (18-50 years old)&#xD;
&#xD;
          -  class 2 and 3 obesity (BMI &gt; 35 kg/m2)&#xD;
&#xD;
          -  moderate to severe callosities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intractable plantar keratosis (IPK), which are painful plantar calluses located under&#xD;
             the metatarsal heads.&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  menopause&#xD;
&#xD;
          -  diseases that cause water retention (edema, renal insufficiency, hypertension, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bård Kulseng, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>St. Olavs Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Obesity policlinic of St. Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Roekenes J, Strommen M, Kulseng B, Martins C. The Impact of Feet Callosities, Arm Posture, and Usage of Electrolyte Wipes on Body Composition by Bioelectrical Impedance Analysis in Morbidly Obese Adults. Obes Facts. 2015;8(6):364-72. doi: 10.1159/000442033. Epub 2015 Nov 20.</citation>
    <PMID>26584161</PMID>
  </results_reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>June 14, 2016</last_update_submitted>
  <last_update_submitted_qc>June 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Body constitution</keyword>
  <keyword>Anthropometry</keyword>
  <keyword>Electric impedance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Callosities</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01676883
org study id: 2012/1018
nct id: NCT01676883
lead sponsor: 
collaborator: 
has dmc: No
Studies have confirmed the association between plantar callosities and severely obese
      individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for
      estimating body composition because it is easy to use, noninvasive, relatively inexpensive,
      and can be performed across a wide range of subjects.

      Our hypotheses for this study are: (1)plantar callosities influence the body composition
      measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the
      percentage of body fat compared with air-displacement plethysmography (BodPod).
As the prevalence of obesity continues to increase, many parts of the world are progressively
      facing a rise in the number of people who fall under WHO obesity class 2 and 3. Since severe
      obesity is characterized by large alterations in body compartments when compared to
      overweight or non-obese individuals, there is a need for the evaluation of the body
      composition of severely obese persons. There is very few published research available on what
      methods of body composition measurements can be used on this population.

      Other studies have also shown the tendency of bioelectrical impedance analysis (BIA)
      instruments to underestimate percentage of fat mass and overestimate the percentage of fat
      free nass, compared with gold-standard techniques. We think that plantar callosities might
      have contributed to the lack of accurate measurements. Thus, the primary aim of this study is
      to determine whether plantar callosities influence the validity of body composition
      measurements obtained by BIA, using the InBody 720. The secondary aim is to assess the
      validity of the body composition measurements obtained by BIA (InBody 720) in severely obese
      individuals, using air-displacement plethysmography (BodPod) as the gold standard.
      Additionally, we will explore various sources of error using test-retest reliabilities by
      measuring body composition with different arm postures. We will examine this further to rule
      out the possibility of "positions of measurement" as a potential confounder of this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Body composition
time frame: 1 day
description: Bioelectric impedance (using InBody 720) at three standardized arm postures angled at 15, 45 and 90 degrees, in randomized order; Air displacement plethysmography (ADP,using BodPod)
arm group label: body composition assessment
arm group type: Experimental
description: Bioelectric impedance measurement pre- and post removal of calluses and corns (pedicure), then air-displacement plethysmography (gold standard)
intervention type: Device
intervention name: Bioelectric impedance
description: removal of calluses and corns by pedicure
arm group label: body composition assessment
other name: BIA
intervention type: Device
intervention name: Air displacement plethysmography
arm group label: body composition assessment
other name: ADP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Bård Kulseng, MD PhD
role: Study Director
affiliation: St. Olavs Hospital
facility: 
country: Norway
citation: Roekenes J, Strommen M, Kulseng B, Martins C. The Impact of Feet Callosities, Arm Posture, and Usage of Electrolyte Wipes on Body Composition by Bioelectrical Impedance Analysis in Morbidly Obese Adults. Obes Facts. 2015;8(6):364-72. doi: 10.1159/000442033. Epub 2015 Nov 20.
PMID: 26584161
responsible party type: Sponsor
mesh term: Callosities
mesh term: Obesity, Morbid
sharing ipd: Undecided