An observational study in Metabolism Disorder and Overweight and Obesity, sponsored by Ospedale San Donato. Completed at 1 site in Italy. Open to participants aged 20 Years to 86 Years. Per ClinicalTrials.gov, last updated 2017-07-28.
Sponsored by Ospedale San Donato · Observational
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
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This study's enrollment of 355 is above the median of 135 across 1,283 observational studies indexed under Obesity.
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To collect clinical data of a total population comprising patients referred to our Endocrinology-Diabetes Outpatient Clinic, in the period from April 2012 through October 2016.
In this retrospective study, will be considered patients with an age ranging from 20 to 86 years, with overweight (25 ≤ BMI ≤ 29.9) or obesity (BMI ≥ 30), requiring dietary intervention for weight control.
Statistical analysis will perform on overweight and obese patients divided into two subgroups: IC group and NO-IC group.
Anthropometric status and metabolic biomarkers will re-evaluated at check-ups performed after 3 months, 6 months, 12 months and 18 months from the baseline.
Exclusion Criteria:
Group who performed indirect calorimetry. REE measured by indirect calorimetry.
Diagnostic Test: Indirect calorimetry
Group who did not perform indirect calorimetry. Resting Energy Expenditure calculated by Harris-Benedict formula
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)
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)
Time frame: 18 months
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)
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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.
Time frame: 18 months
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.
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
Hemoglobin in Indirect Calorimetry group and in NO Indirect Calorimetry Group
to identify differences in glycated hemoglobin (%) variation between IC and NO-IC groups
Time frame: 18 months
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
Time frame: 18 months
Plan to share: No
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Ospedale San Donato