Use of Indirect Calorimetry in Obesity

NCT03233568 | Completed

• 1 other identifier: CALO/Obesity
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolism Disorder; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group

  18 months

• BMI in male/female in Indirect Calorimetry group and in NO indirect

  18 months

Other Outcomes (9)

• Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations

  18 months

• BMI in adequate to predicted REE and in NOT adequate to predicted REE subpopulations

  18 months

• Weight in subjects with RQ<0.9 and subjects with RQ>0.9

  18 months

Study Arms (2)

Indirect Calorimetry group (IC group)

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

Diagnostic Test: Indirect calorimetry

NO Indirect Calorimetry group (NO-IC group)

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

Interventions

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)

Indirect Calorimetry group (IC group)

Eligibility Criteria

• Age: 20 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• BMI\<25
• Age \<20
• Age \>86

Sponsors & Collaborators

• Ospedale San Donato: lead

Study Sites (1)

San Donato Hospital

San Donato Milanese, MI, 20097, Italy

Location

Related Publications (1)

• Massarini S, Ferrulli A, Ambrogi F, Macri C, Terruzzi I, Benedini S, Luzi L. Routine resting energy expenditure measurement increases effectiveness of dietary intervention in obesity. Acta Diabetol. 2018 Jan;55(1):75-85. doi: 10.1007/s00592-017-1064-0. Epub 2017 Nov 3.

  PMID: 29101542 DERIVED

MeSH Terms

Conditions

Metabolic Diseases; Overweight; Obesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Livio Luzi, Professor

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 28, 2017
• Study Start: April 1, 2012
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)