<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/NCT03233568</url>
  </required_header>
  <id_info>
    <org_study_id>CALO/Obesity</org_study_id>
    <nct_id>NCT03233568</nct_id>
  </id_info>
  <brief_title>Use of Indirect Calorimetry in Obesity</brief_title>
  <official_title>Use of Indirect Calorimetry in Dietary Setting in Obese Subjects: Retrospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale San Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale San Donato</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will retrospectively analyze and compare data of 2 groups of overweight and&#xD;
      obese patients: subjects who followed a diet based on Resting Energy Expenditure (REE)&#xD;
      measured by indirect calorimetry and subjects who followed a diet based on REE estimated by&#xD;
      the Harris-Benedict equation. Propensity score adjustment will be used to adjust for known&#xD;
      differences between the 2 groups&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2012</start_date>
  <completion_date type="Actual">October 31, 2016</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group</measure>
    <time_frame>18 months</time_frame>
    <description>To compare body weight variation (kg) in two groups of overweight or obese patients: subjects who followed a diet formulated on REE measured by IC (IC group) and subjects who followed a diet based on REE predicted by the Harris-Benedict formula (NO-IC group)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI in Indirect Calorimetry group and in NO Indirect Calorimetry</measure>
    <time_frame>18 months</time_frame>
    <description>To compare BMI variation (kg/m^2) in two groups of overweight or obese patients: subjects who followed a diet formulated on REE measured by IC (IC group) and subjects who followed a diet based on REE predicted by the Harris-Benedict formula (NO-IC group)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group</measure>
    <time_frame>18 months</time_frame>
    <description>To identify gender differences in weight variation (kg) between IC and NO-IC groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI in male/female in Indirect Calorimetry group and in NO indirect</measure>
    <time_frame>18 months</time_frame>
    <description>To identify gender differences in BMI variation (kg/m^2) between IC and NO-IC groups</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations</measure>
    <time_frame>18 months</time_frame>
    <description>to compare body weight variation (kg) in two sub-populations of the IC-group: subjects with adequate to predicted REE and subjects with not adequate to predicted REE</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI in adequate to predicted REE and in NOT adequate to predicted REE subpopulations</measure>
    <time_frame>18 months</time_frame>
    <description>to compare BMI variation in two sub-populations of the IC-group: subjects with adequate to predicted REE and subjects with not adequate to predicted REE</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight in subjects with RQ&lt;0.9 and subjects with RQ&gt;0.9</measure>
    <time_frame>18 months</time_frame>
    <description>to compare body weight variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ &gt; 0.9.</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI in subjects with RQ&lt;0.9 and subjects with RQ&gt;0.9</measure>
    <time_frame>18 months</time_frame>
    <description>BMI variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ &gt; 0.9.</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucose in Indirect Calorimetry group and in NO Indirect Calorimetry Group</measure>
    <time_frame>18 months</time_frame>
    <description>to identify differences in glucose (mg/dl) variation between IC and NO-IC groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Tryglycerides in Indirect Calorimetry group and in NO Indirect Calorimetry Group</measure>
    <time_frame>18 months</time_frame>
    <description>to identify differences in tryglycerides (mg/dl) variation between IC and NO-IC groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Total cholesterol (mg/dl) in Indirect Calorimetry group and in NO Indirect Calorimetry Group</measure>
    <time_frame>18 months</time_frame>
    <description>to identify differences in cholesterol variation between IC and NO-IC groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin in Indirect Calorimetry group and in NO Indirect Calorimetry Group</measure>
    <time_frame>18 months</time_frame>
    <description>to identify differences in glycated hemoglobin (%) variation between IC and NO-IC groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Uric acid in Indirect Calorimetry group and in NO Indirect Calorimetry Group</measure>
    <time_frame>18 months</time_frame>
    <description>to identify differences in uric acid (mg/dl) variation between IC and NO-IC groups</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">355</enrollment>
  <condition>Metabolism Disorder</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Indirect Calorimetry group (IC group)</arm_group_label>
    <description>Group who performed indirect calorimetry. REE measured by indirect calorimetry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NO Indirect Calorimetry group (NO-IC group)</arm_group_label>
    <description>Group who did not perform indirect calorimetry. Resting Energy Expenditure calculated by Harris-Benedict formula</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Indirect calorimetry</intervention_name>
    <description>Indirect calorimetry will be performed by using an open-circuit calorimeter (Sensor Medics, Italy). Indirect calorimetry is the reference method for energy expenditure determination. A canopy hood covered the patient's head and expired air is extracted by a pump to be analyzed by metabolic cart sensors; flow rate is directly measured with a digital turbine flowmeter. After an overnight fast, patients will asked to lay supine in complete physical rest, not sleeping or talking for approximately 20-25 minutes, at a room temperature ranged between 22 and 24°C. The mean REE for each participant considers the last 15-20 minutes of measurements corresponding to steady state.&#xD;
Software of calorimeter will be set for minute-by-minute reading report of VO2 (Oxygen flow) and VCO2 (Carbon dioxide flow) measurement.&#xD;
Parameters obtained by Indirect Calorimetry will be the Resting Energy Expenditure and the Respiratory Quotient (RQ)</description>
    <arm_group_label>Indirect Calorimetry group (IC group)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        To collect clinical data of a total population comprising patients referred to our&#xD;
        Endocrinology-Diabetes Outpatient Clinic, in the period from April 2012 through October&#xD;
        2016.&#xD;
&#xD;
        In this retrospective study, will be considered patients with an age ranging from 20 to 86&#xD;
        years, with overweight (25 ≤ BMI ≤ 29.9) or obesity (BMI ≥ 30), requiring dietary&#xD;
        intervention for weight control.&#xD;
&#xD;
        Statistical analysis will perform on overweight and obese patients divided into two&#xD;
        subgroups: IC group and NO-IC group.&#xD;
&#xD;
        Anthropometric status and metabolic biomarkers will re-evaluated at check-ups performed&#xD;
        after 3 months, 6 months, 12 months and 18 months from the baseline.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;25&#xD;
&#xD;
          -  Age ranging from 20 to 86 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI&lt;25&#xD;
&#xD;
          -  Age &lt;20&#xD;
&#xD;
          -  Age &gt;86&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>86 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Livio Luzi, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Policlinico S. Donato</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Donato Hospital</name>
      <address>
        <city>San Donato Milanese</city>
        <state>MI</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale San Donato</investigator_affiliation>
    <investigator_full_name>Anna Ferrulli</investigator_full_name>
    <investigator_title>Sub-Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Diseases</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/NCT03233568
org study id: CALO/Obesity
nct id: NCT03233568
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators will retrospectively analyze and compare data of 2 groups of overweight and
      obese patients: subjects who followed a diet based on Resting Energy Expenditure (REE)
      measured by indirect calorimetry and subjects who followed a diet based on REE estimated by
      the Harris-Benedict equation. Propensity score adjustment will be used to adjust for known
      differences between the 2 groups
observational model: Case-Control
time perspective: Retrospective
measure: Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group
time frame: 18 months
description: To compare body weight variation (kg) in two groups of overweight or obese patients: subjects who followed a diet formulated on REE measured by IC (IC group) and subjects who followed a diet based on REE predicted by the Harris-Benedict formula (NO-IC group)
measure: BMI in Indirect Calorimetry group and in NO Indirect Calorimetry
time frame: 18 months
description: To compare BMI variation (kg/m^2) in two groups of overweight or obese patients: subjects who followed a diet formulated on REE measured by IC (IC group) and subjects who followed a diet based on REE predicted by the Harris-Benedict formula (NO-IC group)
measure: Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group
time frame: 18 months
description: To identify gender differences in weight variation (kg) between IC and NO-IC groups
measure: BMI in male/female in Indirect Calorimetry group and in NO indirect
time frame: 18 months
description: To identify gender differences in BMI variation (kg/m^2) between IC and NO-IC groups
measure: Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations
time frame: 18 months
description: to compare body weight variation (kg) in two sub-populations of the IC-group: subjects with adequate to predicted REE and subjects with not adequate to predicted REE
measure: BMI in adequate to predicted REE and in NOT adequate to predicted REE subpopulations
time frame: 18 months
description: to compare BMI variation in two sub-populations of the IC-group: subjects with adequate to predicted REE and subjects with not adequate to predicted REE
measure: Weight in subjects with RQ<0.9 and subjects with RQ>0.9
time frame: 18 months
description: to compare body weight variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ > 0.9.
measure: BMI in subjects with RQ<0.9 and subjects with RQ>0.9
time frame: 18 months
description: BMI variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ > 0.9.
measure: Glucose in Indirect Calorimetry group and in NO Indirect Calorimetry Group
time frame: 18 months
description: to identify differences in glucose (mg/dl) variation between IC and NO-IC groups
measure: Tryglycerides in Indirect Calorimetry group and in NO Indirect Calorimetry Group
time frame: 18 months
description: to identify differences in tryglycerides (mg/dl) variation between IC and NO-IC groups
measure: Total cholesterol (mg/dl) in Indirect Calorimetry group and in NO Indirect Calorimetry Group
time frame: 18 months
description: to identify differences in cholesterol variation between IC and NO-IC groups
measure: Hemoglobin in Indirect Calorimetry group and in NO Indirect Calorimetry Group
time frame: 18 months
description: to identify differences in glycated hemoglobin (%) variation between IC and NO-IC groups
measure: Uric acid in Indirect Calorimetry group and in NO Indirect Calorimetry Group
time frame: 18 months
description: to identify differences in uric acid (mg/dl) variation between IC and NO-IC groups
arm group label: Indirect Calorimetry group (IC group)
description: Group who performed indirect calorimetry. REE measured by indirect calorimetry.
arm group label: NO Indirect Calorimetry group (NO-IC group)
description: Group who did not perform indirect calorimetry. Resting Energy Expenditure calculated by Harris-Benedict formula
intervention type: Diagnostic Test
intervention name: Indirect calorimetry
description: Indirect calorimetry will be performed by using an open-circuit calorimeter (Sensor Medics, Italy). Indirect calorimetry is the reference method for energy expenditure determination. A canopy hood covered the patient's head and expired air is extracted by a pump to be analyzed by metabolic cart sensors; flow rate is directly measured with a digital turbine flowmeter. After an overnight fast, patients will asked to lay supine in complete physical rest, not sleeping or talking for approximately 20-25 minutes, at a room temperature ranged between 22 and 24°C. The mean REE for each participant considers the last 15-20 minutes of measurements corresponding to steady state.
Software of calorimeter will be set for minute-by-minute reading report of VO2 (Oxygen flow) and VCO2 (Carbon dioxide flow) measurement.
Parameters obtained by Indirect Calorimetry will be the Resting Energy Expenditure and the Respiratory Quotient (RQ)
arm group label: Indirect Calorimetry group (IC group)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 86 Years
healthy volunteers: No
last name: Livio Luzi, Professor
role: Principal Investigator
affiliation: IRCCS Policlinico S. Donato
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Ospedale San Donato
investigator full name: Anna Ferrulli
investigator title: Sub-Investigator
mesh term: Obesity
mesh term: Overweight
mesh term: Metabolic Diseases
sharing ipd: No