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NCT Number: NCT03233568

Use of Indirect Calorimetry in Obesity

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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Key information

Conditions

Metabolism Disorder Body Weight Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Donato Hospital

San Donato Milanese, MI, 20097, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI >25
  • Age ranging from 20 to 86 years

Exclusion criteria

  • BMI<25
  • Age <20
  • Age >86

Treatment and study plan

indirect calorimetry

Diagnostic Test

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)

Primary outcomes

  1. Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group

    Time frame: 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

    Time frame: 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 outcomes

  1. Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group

    Time frame: 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

    Time frame: 18 months

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

Other outcomes

  1. Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Ospedale San Donato

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2017
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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