<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/NCT03285074</url>
  </required_header>
  <id_info>
    <org_study_id>99-IRB-016-XD</org_study_id>
    <nct_id>NCT03285074</nct_id>
  </id_info>
  <brief_title>The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease</brief_title>
  <official_title>The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</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>
      Unlike the general population, a higher body mass index (BMI) is associated with greater&#xD;
      survival among patients with chronic kidney disease (CKD). However, obesity is defined as&#xD;
      excess body fat that associated with clearly elevated health risks according to the World&#xD;
      Health Organization. In addition, muscle wasting is prevalent among CKD subjects. Thus, we&#xD;
      hypothesized that different definition of obesity, based on BMI or body fat percentage, might&#xD;
      have different impact on clinical outcomes among CKD population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2011</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2012</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>all-cause mortality</measure>
    <time_frame>medium follow up 4.9 years</time_frame>
    <description>all-cause mortality</description>
  </primary_outcome>
  <enrollment type="Actual">326</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Obesity</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with nondialysis CKD with eGFR &lt; 60ml/min/1.73m2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with non-dialysis CKD defined as estimated glomerular filtration rate (eGFR)&#xD;
             &lt;60 ml/min/1.73 m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with liver cirrhosis&#xD;
&#xD;
          -  subjects with malignancy&#xD;
&#xD;
          -  subjects with an acute cardiovascular event within the 3 months before screening for&#xD;
             inclusion&#xD;
&#xD;
          -  amputee&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  subjects with pacemaker&#xD;
&#xD;
          -  subjects with metallic implant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Szu-Chun Hung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of nephrology, Taipei Tzu Chi Hospital</affiliation>
  </overall_official>
  <results_reference>
    <citation>Sharma D, Hawkins M, Abramowitz MK. Association of sarcopenia with eGFR and misclassification of obesity in adults with CKD in the United States. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2079-88. doi: 10.2215/CJN.02140214. Epub 2014 Nov 12.</citation>
    <PMID>25392147</PMID>
  </results_reference>
  <results_reference>
    <citation>Agarwal R, Bills JE, Light RP. Diagnosing obesity by body mass index in chronic kidney disease: an explanation for the &quot;obesity paradox?&quot;. Hypertension. 2010 Nov;56(5):893-900. doi: 10.1161/HYPERTENSIONAHA.110.160747. Epub 2010 Sep 27.</citation>
    <PMID>20876448</PMID>
  </results_reference>
  <results_reference>
    <citation>Gracia-Iguacel C, Qureshi AR, Avesani CM, Heimburger O, Huang X, Lindholm B, Barany P, Ortiz A, Stenvinkel P, Carrero JJ. Subclinical versus overt obesity in dialysis patients: more than meets the eye. Nephrol Dial Transplant. 2013 Nov;28 Suppl 4:iv175-81. doi: 10.1093/ndt/gft024.</citation>
    <PMID>24179011</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</investigator_affiliation>
    <investigator_full_name>Szu-Chun Hung</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Diagnostic discordance of obesity</keyword>
  <keyword>all-cause mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Obesity</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/NCT03285074
org study id: 99-IRB-016-XD
nct id: NCT03285074
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Unlike the general population, a higher body mass index (BMI) is associated with greater
      survival among patients with chronic kidney disease (CKD). However, obesity is defined as
      excess body fat that associated with clearly elevated health risks according to the World
      Health Organization. In addition, muscle wasting is prevalent among CKD subjects. Thus, we
      hypothesized that different definition of obesity, based on BMI or body fat percentage, might
      have different impact on clinical outcomes among CKD population.
observational model: Cohort
time perspective: Prospective
measure: all-cause mortality
time frame: medium follow up 4.9 years
description: all-cause mortality
intervention type: Other
intervention name: No intervention
description: No intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Szu-Chun Hung, MD
role: Principal Investigator
affiliation: Division of nephrology, Taipei Tzu Chi Hospital
citation: Sharma D, Hawkins M, Abramowitz MK. Association of sarcopenia with eGFR and misclassification of obesity in adults with CKD in the United States. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2079-88. doi: 10.2215/CJN.02140214. Epub 2014 Nov 12.
PMID: 25392147
citation: Agarwal R, Bills JE, Light RP. Diagnosing obesity by body mass index in chronic kidney disease: an explanation for the "obesity paradox?". Hypertension. 2010 Nov;56(5):893-900. doi: 10.1161/HYPERTENSIONAHA.110.160747. Epub 2010 Sep 27.
PMID: 20876448
citation: Gracia-Iguacel C, Qureshi AR, Avesani CM, Heimburger O, Huang X, Lindholm B, Barany P, Ortiz A, Stenvinkel P, Carrero JJ. Subclinical versus overt obesity in dialysis patients: more than meets the eye. Nephrol Dial Transplant. 2013 Nov;28 Suppl 4:iv175-81. doi: 10.1093/ndt/gft024.
PMID: 24179011
responsible party type: Principal Investigator
investigator affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
investigator full name: Szu-Chun Hung
investigator title: MD
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Obesity
sharing ipd: No