Use of Indirect Calorimetry in Obesity

NCT ID: NCT03233568

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

355 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-01

Study Completion Date

2016-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Metabolism Disorder Overweight and Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Indirect Calorimetry group (IC group)

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

Indirect calorimetry

Intervention Type 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)

NO Indirect Calorimetry group (NO-IC group)

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

No interventions assigned to this group

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Donato

OTHER

Sponsor Role lead

Responsible Party

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Anna Ferrulli

Sub-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Livio Luzi, Professor

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico S. Donato

Locations

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San Donato Hospital

San Donato Milanese, MI, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 29101542 (View on PubMed)

Other Identifiers

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CALO/Obesity

Identifier Type: -

Identifier Source: org_study_id

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