Use of Indirect Calorimetry in Obesity

Sponsor
Ospedale San Donato (Other)
Overall Status
Completed
CT.gov ID
NCT03233568
Collaborator
(none)
355
1
55
6.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Indirect calorimetry

Study Design

Study Type:
Observational
Actual Enrollment :
355 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Use of Indirect Calorimetry in Dietary Setting in Obese Subjects: Retrospective Observational Study
Actual Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Oct 31, 2016
Actual Study Completion Date :
Oct 31, 2016

Arms and Interventions

Arm Intervention/Treatment
Indirect Calorimetry group (IC group)

Group who performed indirect calorimetry. REE measured by indirect calorimetry.

Diagnostic Test: Indirect calorimetry
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)

NO Indirect Calorimetry group (NO-IC group)

Group who did not perform indirect calorimetry. Resting Energy Expenditure calculated by Harris-Benedict formula

Outcome Measures

Primary Outcome Measures

  1. Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group [18 months]

    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)

  2. BMI in Indirect Calorimetry group and in NO Indirect Calorimetry [18 months]

    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)

Secondary Outcome Measures

  1. Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group [18 months]

    To identify gender differences in weight variation (kg) between IC and NO-IC groups

  2. BMI in male/female in Indirect Calorimetry group and in NO indirect [18 months]

    To identify gender differences in BMI variation (kg/m^2) between IC and NO-IC groups

Other Outcome Measures

  1. Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations [18 months]

    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

  2. BMI in adequate to predicted REE and in NOT adequate to predicted REE subpopulations [18 months]

    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

  3. Weight in subjects with RQ<0.9 and subjects with RQ>0.9 [18 months]

    to compare body weight variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ > 0.9.

  4. BMI in subjects with RQ<0.9 and subjects with RQ>0.9 [18 months]

    BMI variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ > 0.9.

  5. Glucose in Indirect Calorimetry group and in NO Indirect Calorimetry Group [18 months]

    to identify differences in glucose (mg/dl) variation between IC and NO-IC groups

  6. Tryglycerides in Indirect Calorimetry group and in NO Indirect Calorimetry Group [18 months]

    to identify differences in tryglycerides (mg/dl) variation between IC and NO-IC groups

  7. Total cholesterol (mg/dl) in Indirect Calorimetry group and in NO Indirect Calorimetry Group [18 months]

    to identify differences in cholesterol variation between IC and NO-IC groups

  8. Hemoglobin in Indirect Calorimetry group and in NO Indirect Calorimetry Group [18 months]

    to identify differences in glycated hemoglobin (%) variation between IC and NO-IC groups

  9. Uric acid in Indirect Calorimetry group and in NO Indirect Calorimetry Group [18 months]

    to identify differences in uric acid (mg/dl) variation between IC and NO-IC groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 86 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • BMI >25

  • Age ranging from 20 to 86 years

Exclusion Criteria:
  • BMI<25

  • Age <20

  • Age >86

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Donato Hospital San Donato Milanese MI Italy 20097

Sponsors and Collaborators

  • Ospedale San Donato

Investigators

  • Principal Investigator: Livio Luzi, Professor, IRCCS Policlinico San Donato

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anna Ferrulli, Sub-Investigator, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT03233568
Other Study ID Numbers:
  • CALO/Obesity
First Posted:
Jul 28, 2017
Last Update Posted:
Jul 28, 2017
Last Verified:
Jul 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2017