Skip to content

Use of Indirect Calorimetry in Obesity

Use of Indirect Calorimetry in Dietary Setting in Obese Subjects: Retrospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03233568
Enrollment
355
Registered
2017-07-28
Start date
2012-04-01
Completion date
2016-10-31
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism Disorder, Overweight and Obesity

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

Interventions

DIAGNOSTIC_TESTIndirect 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)

Sponsors

Ospedale San Donato
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 86 Years
Healthy volunteers
No

Inclusion criteria

* BMI \>25 * Age ranging from 20 to 86 years

Exclusion criteria

* BMI\<25 * Age \<20 * Age \>86

Design outcomes

Primary

MeasureTime frameDescription
Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group18 monthsTo 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)
BMI in Indirect Calorimetry group and in NO Indirect Calorimetry18 monthsTo 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

MeasureTime frameDescription
Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group18 monthsTo identify gender differences in weight variation (kg) between IC and NO-IC groups
BMI in male/female in Indirect Calorimetry group and in NO indirect18 monthsTo identify gender differences in BMI variation (kg/m\^2) between IC and NO-IC groups

Other

MeasureTime frameDescription
Weight in subjects with RQ<0.9 and subjects with RQ>0.918 monthsto compare body weight variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ \> 0.9.
BMI in subjects with RQ<0.9 and subjects with RQ>0.918 monthsBMI variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ \> 0.9.
Tryglycerides in Indirect Calorimetry group and in NO Indirect Calorimetry Group18 monthsto identify differences in tryglycerides (mg/dl) variation between IC and NO-IC groups
Hemoglobin in Indirect Calorimetry group and in NO Indirect Calorimetry Group18 monthsto identify differences in glycated hemoglobin (%) variation between IC and NO-IC groups
Uric acid in Indirect Calorimetry group and in NO Indirect Calorimetry Group18 monthsto identify differences in uric acid (mg/dl) variation between IC and NO-IC groups
Glucose in Indirect Calorimetry group and in NO Indirect Calorimetry Group18 monthsto identify differences in glucose (mg/dl) variation between IC and NO-IC groups
Total cholesterol (mg/dl) in Indirect Calorimetry group and in NO Indirect Calorimetry Group18 monthsto identify differences in cholesterol variation between IC and NO-IC groups
Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations18 monthsto 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
BMI in adequate to predicted REE and in NOT adequate to predicted REE subpopulations18 monthsto 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026