Use of Indirect Calorimetry in Obesity

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 20 to 86 years
• All sexes
• No healthy volunteers
• Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Metabolism Disorder, Overweight and Obesity

Being tested

Indirect calorimetry

Medical subject headings

Metabolic Diseases, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Indirect calorimetryDiagnostic 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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)

   Measured: 18 months

2. 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)

   Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Jul 2017
2. Study start1 Apr 2012
3. Primary completion31 Oct 2016
4. Study completion31 Oct 2016

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Metabolism DisorderStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.