Use of Indirect Calorimetry in Obesity

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233568
• Other study ID #: CALO/Obesity
• Status: Completed
• Phase: N/A
• First received: July 21, 2017
• Last updated: July 27, 2017
• Start date: April 1, 2012
• Est. completion date: October 31, 2016

Study information

• Verified date: July 2017
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 86 Years

Eligibility

Inclusion Criteria:

• BMI >25

• Age ranging from 20 to 86 years

Exclusion Criteria:

• BMI<25

• Age <20

• Age >86

Related Conditions & MeSH terms

• Metabolic Diseases
• Metabolism Disorder
• Obesity
• Overweight
• Overweight and Obesity

Intervention

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)

Locations

Country	Name	City	State
Italy	San Donato Hospital	San Donato Milanese	MI

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations	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	18 months
Other	BMI in adequate to predicted REE and in NOT adequate to predicted REE subpopulations	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	18 months
Other	Weight in subjects with RQ<0.9 and subjects with RQ>0.9	to compare body weight variation in 2 subpopulation of the IC group: subjects with an RQ = 0.9 and subjects with RQ > 0.9.	18 months
Other	BMI in subjects with RQ<0.9 and subjects with RQ>0.9	BMI variation in 2 subpopulation of the IC group: subjects with an RQ = 0.9 and subjects with RQ > 0.9.	18 months
Other	Glucose in Indirect Calorimetry group and in NO Indirect Calorimetry Group	to identify differences in glucose (mg/dl) variation between IC and NO-IC groups	18 months
Other	Tryglycerides in Indirect Calorimetry group and in NO Indirect Calorimetry Group	to identify differences in tryglycerides (mg/dl) variation between IC and NO-IC groups	18 months
Other	Total cholesterol (mg/dl) in Indirect Calorimetry group and in NO Indirect Calorimetry Group	to identify differences in cholesterol variation between IC and NO-IC groups	18 months
Other	Hemoglobin in Indirect Calorimetry group and in NO Indirect Calorimetry Group	to identify differences in glycated hemoglobin (%) variation between IC and NO-IC groups	18 months
Other	Uric acid in Indirect Calorimetry group and in NO Indirect Calorimetry Group	to identify differences in uric acid (mg/dl) variation between IC and NO-IC groups	18 months
Primary	Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group	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)	18 months
Primary	BMI in Indirect Calorimetry group and in NO Indirect Calorimetry	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)	18 months
Secondary	Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group	To identify gender differences in weight variation (kg) between IC and NO-IC groups	18 months
Secondary	BMI in male/female in Indirect Calorimetry group and in NO indirect	To identify gender differences in BMI variation (kg/m^2) between IC and NO-IC groups	18 months