Clinical trial NCT03233568: Use of Indirect Calorimetry in Obesity
Official title: Use of Indirect Calorimetry in Dietary Setting in Obese Subjects: Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolism Disorder
Overweight and Obesity
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 355
Sex: ALL
Minimum age (years): 20
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group
timeFrame: 18 months
measure: BMI in Indirect Calorimetry group and in NO Indirect Calorimetry
timeFrame: 18 months
Secondary outcomes:
measure: Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group
timeFrame: 18 months
measure: BMI in male/female in Indirect Calorimetry group and in NO indirect
timeFrame: 18 months
Other outcomes:
measure: Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations
timeFrame: 18 months
measure: BMI in adequate to predicted REE and in NOT adequate to predicted REE subpopulations
timeFrame: 18 months
measure: Weight in subjects with RQ<0.9 and subjects with RQ>0.9
timeFrame: 18 months
measure: BMI in subjects with RQ<0.9 and subjects with RQ>0.9
timeFrame: 18 months
measure: Glucose in Indirect Calorimetry group and in NO Indirect Calorimetry Group
timeFrame: 18 months
measure: Tryglycerides in Indirect Calorimetry group and in NO Indirect Calorimetry Group
timeFrame: 18 months
measure: Total cholesterol (mg/dl) in Indirect Calorimetry group and in NO Indirect Calorimetry Group
timeFrame: 18 months
measure: Hemoglobin in Indirect Calorimetry group and in NO Indirect Calorimetry Group
timeFrame: 18 months
measure: Uric acid in Indirect Calorimetry group and in NO Indirect Calorimetry Group
timeFrame: 18 months
Locations:
city: San Donato Milanese
country: Italy
facility: San Donato Hospital
state: MI
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Livio Luzi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.