<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/NCT02975427</url>
  </required_header>
  <id_info>
    <org_study_id>KA12/192</org_study_id>
    <nct_id>NCT02975427</nct_id>
  </id_info>
  <brief_title>Bioimpedance Analysis for Follow-up of Dieters</brief_title>
  <acronym>BIA</acronym>
  <official_title>Abdominal Bioelectric Impedance for Follow-up of Dieters: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskent University Ankara Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baskent University Ankara Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, single arm, dietary intervention study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study was conducted during the period from December 2011 through June 2013&#xD;
      in the Department of Endocrinology and Metabolism of Başkent University.&#xD;
&#xD;
      We enrolled 185 participants who were admitted to hospital for weight loss therapy. After&#xD;
      initial evaluation, all participants were prescribed an appropriate diet with caloric&#xD;
      restriction and an exercise program and underwent a follow-up examination 3±1 months later.&#xD;
      At the end of the follow up, 103 participants attended to the research. Anthropometric,&#xD;
      bioimpedance and laboratory measurements performed at baseline and second visit. We&#xD;
      calculated the difference in anthropometric, bioimpedance and laboratory measurements between&#xD;
      the first and second evaluations. Correlation analysis, multivariate linear regression&#xD;
      analysis and receiver operating characteristic analysis performed to assess associations of&#xD;
      laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis&#xD;
      (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine&#xD;
      whether abdominal BIA was better than simple anthropometric measurements and conventional BIA&#xD;
      for assessing changes in metabolic variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Value of abdominal BIA for the follow up of dieting individual</measure>
    <time_frame>3 months (plus or minus 1 month)</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">103</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Diet group</arm_group_label>
    <description>All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet group</intervention_name>
    <description>All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.</description>
    <arm_group_label>Diet group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One hundred and eighty five participants who were admitted to hospital for weight loss&#xD;
        therapy enrolled to the study. After initial evaluation, all participants were prescribed&#xD;
        an appropriate diet with caloric restriction and an exercise program and underwent a&#xD;
        follow-up examination 3±1 months later. A total of 134 participants reported for the second&#xD;
        visit; 51 did not. Thirty one participants who, at the second visit, reported that they&#xD;
        failed to adhere to the diet were excluded from the analysis . Ultimately, data from 103&#xD;
        participants who reported that they adhered to the diet were included in the analysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 18 to 70 years without chronic disease, cancer, a pacemaker, cardiac&#xD;
             valve replacement, malabsorption syndrome, previous history of gastrointestinal&#xD;
             surgery, thyroid disease, pregnancy, or a history of surgery during the previous 3&#xD;
             months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants receiving oral antidiabetic drugs, insulin, any treatment for obesity,&#xD;
             steroids or hormonal drugs, over-the-counter drugs for weight loss, any kind of&#xD;
             phytodrug, or any drug that could affect glucose metabolism. We also excluded patients&#xD;
             who used any of these drugs after the initial evaluation.&#xD;
&#xD;
          -  Participants who, at the second visit, reported that they failed to adhere to the&#xD;
             diet.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yusuf Bozkuş, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baskent University Ankara Hospital</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baskent University Ankara Hospital</investigator_affiliation>
    <investigator_full_name>Yusuf Bozkuş</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Diet</keyword>
  <keyword>Abdominal bioelectrical impedance analysis</keyword>
  <keyword>Anthropometry</keyword>
  <keyword>Insulin resistance</keyword>
  <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/NCT02975427
org study id: KA12/192
nct id: NCT02975427
lead sponsor: 
has dmc: No
Prospective, single arm, dietary intervention study.
This prospective study was conducted during the period from December 2011 through June 2013
      in the Department of Endocrinology and Metabolism of Başkent University.

      We enrolled 185 participants who were admitted to hospital for weight loss therapy. After
      initial evaluation, all participants were prescribed an appropriate diet with caloric
      restriction and an exercise program and underwent a follow-up examination 3±1 months later.
      At the end of the follow up, 103 participants attended to the research. Anthropometric,
      bioimpedance and laboratory measurements performed at baseline and second visit. We
      calculated the difference in anthropometric, bioimpedance and laboratory measurements between
      the first and second evaluations. Correlation analysis, multivariate linear regression
      analysis and receiver operating characteristic analysis performed to assess associations of
      laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis
      (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine
      whether abdominal BIA was better than simple anthropometric measurements and conventional BIA
      for assessing changes in metabolic variables.
observational model: Cohort
time perspective: Prospective
measure: Value of abdominal BIA for the follow up of dieting individual
time frame: 3 months (plus or minus 1 month)
arm group label: Diet group
description: All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.
intervention type: Other
intervention name: Diet group
description: All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.
arm group label: Diet group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yusuf Bozkuş, Dr.
role: Principal Investigator
affiliation: Baskent University Ankara Hospital
responsible party type: Principal Investigator
investigator affiliation: Baskent University Ankara Hospital
investigator full name: Yusuf Bozkuş
investigator title: Dr.
sharing ipd: No