Use of Indirect Calorimetry in Obesity

Completed

• Conditions: Metabolism Disorder; Overweight and Obesity
• Interventions: Diagnostic Test: Indirect calorimetry

• Registration Number: NCT03233568
• Lead Sponsor: Ospedale San Donato

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-01
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Status Verified: 2017-07
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-27
• Last Update Submitted: 2017-07-27
• Study First Posted: 2017-07-28
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

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

Exclusion Criteria

• BMI<25
• Age <20
• Age >86

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indirect Calorimetry group (IC group)	Indirect calorimetry	Group who performed indirect calorimetry. REE measured by indirect calorimetry.

Primary Outcome Measures

Name	Time	Method
Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group	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)
BMI in Indirect Calorimetry group and in NO Indirect Calorimetry	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)

Secondary Outcome Measures

Name	Time	Method
Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group	18 months	To identify gender differences in weight variation (kg) between IC and NO-IC groups
BMI in male/female in Indirect Calorimetry group and in NO indirect	18 months	To identify gender differences in BMI variation (kg/m\^2) between IC and NO-IC groups

Trial Locations

Locations (1)

San Donato Hospital; 🇮🇹 San Donato Milanese, MI, Italy