<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/NCT04484883</url>
  </required_header>
  <id_info>
    <org_study_id>6/2020</org_study_id>
    <nct_id>NCT04484883</nct_id>
  </id_info>
  <brief_title>Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes</brief_title>
  <official_title>Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</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>
      The present study evaluated the statistical and clinical performance of the six common&#xD;
      equations in subjects with type 2 diabetes adopting indirect calorimetry as reference&#xD;
      standard&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All consecutive subjects with type 2 diabetes referred from June 2012 to December 2019 were&#xD;
      eligible. They were excluded if data on ongoing therapy, anthropometric or laboratory&#xD;
      parameters, or measured REE was not available or if presenting with conditions known to&#xD;
      affect indirect calorimetry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>Baseline</time_frame>
    <description>Body weight in Kilograms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck circumference</measure>
    <time_frame>Baseline</time_frame>
    <description>Neck circumference in cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>At baseline</time_frame>
    <description>Waist circumference in cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>Baseline</time_frame>
    <description>Hip circumference in cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>At baseline</time_frame>
    <description>Body mass index (BMI) (expressed in kg/m^2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting Energy Expenditure (REE)</measure>
    <time_frame>At baseline</time_frame>
    <description>Resting Energy Expenditure (REE) in kcal</description>
  </primary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Observational</description>
    <other_name>Retrospective cohort study</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        250 patients (124 females and 126 males, mean age 61.9 ± 8.5 years)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with type 2 diabetes&#xD;
&#xD;
          -  Available resting energy expenditure assessed by indirect calorimetry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  data on ongoing therapy (e.g. lifestyle measures with or without approved drugs),&#xD;
             anthropometric or laboratory parameters (including white blood count, estimated&#xD;
             glomerular filtration rate, TSH), or REE assessed by the means of indirect calorimetry&#xD;
             could not be retrieved&#xD;
&#xD;
          -  presenting with conditions known to affect indirect calorimetry (e.g. patients with&#xD;
             strenuous exercise on the day before, asymptomatic patients with severe chronic kidney&#xD;
             disease (eGFR &lt; 30 ml/min/ 1.73 m2), increased white blood count, or subnormal TSH)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>National Institute of Gastroenterology IRCCS S. de Bellis</name>
      <address>
        <city>Castellana Grotte</city>
        <state>Bari</state>
        <zip>70013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</investigator_affiliation>
    <investigator_full_name>Gianluigi Giannelli</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04484883
org study id: 6/2020
nct id: NCT04484883
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study evaluated the statistical and clinical performance of the six common
      equations in subjects with type 2 diabetes adopting indirect calorimetry as reference
      standard
All consecutive subjects with type 2 diabetes referred from June 2012 to December 2019 were
      eligible. They were excluded if data on ongoing therapy, anthropometric or laboratory
      parameters, or measured REE was not available or if presenting with conditions known to
      affect indirect calorimetry.
observational model: Cohort
time perspective: Retrospective
measure: Body weight
time frame: Baseline
description: Body weight in Kilograms
measure: Neck circumference
time frame: Baseline
description: Neck circumference in cm
measure: Waist circumference
time frame: At baseline
description: Waist circumference in cm
measure: Hip circumference
time frame: Baseline
description: Hip circumference in cm
measure: Body mass index (BMI)
time frame: At baseline
description: Body mass index (BMI) (expressed in kg/m^2)
measure: Resting Energy Expenditure (REE)
time frame: At baseline
description: Resting Energy Expenditure (REE) in kcal
intervention type: Other
intervention name: Observational
description: Observational
other name: Retrospective cohort study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
investigator full name: Gianluigi Giannelli
investigator title: Clinical Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No