Use of Indirect Calorimetry in Obesity

July 27, 2017 updated by: Anna Ferrulli, Ospedale San Donato

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • San Donato Milanese, MI, Italy, 20097
        • San Donato Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI<25
  • Age <20
  • Age >86

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Indirect Calorimetry group (IC group)
Group who performed indirect calorimetry. REE measured by indirect calorimetry.
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)
NO Indirect Calorimetry group (NO-IC group)
Group who did not perform indirect calorimetry. Resting Energy Expenditure calculated by Harris-Benedict formula

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
18 months
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)
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
18 months
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
18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
18 months
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
18 months
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.
18 months
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.
18 months
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
18 months
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
18 months
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
18 months
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
18 months
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ospedale San Donato

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Livio Luzi, Professor, IRCCS Policlinico San Donato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CALO/Obesity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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