Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes

The present study evaluated the statistical and clinical performance of the six common equations in subjects with type 2 diabetes adopting indirect calorimetry as reference standard

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Observational

Detailed Description

All consecutive subjects with type 2 diabetes referred from June 2012 to December 2019 were eligible. They were excluded if data on ongoing therapy, anthropometric or laboratory parameters, or measured REE was not available or if presenting with conditions known to affect indirect calorimetry.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Italy
  • Bari
    • Castellana Grotte, Bari, Italy, 70013
      • National Institute of Gastroenterology IRCCS S. de Bellis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

250 patients (124 females and 126 males, mean age 61.9 ± 8.5 years)

Description

Inclusion Criteria:

• Patients with type 2 diabetes
• Available resting energy expenditure assessed by indirect calorimetry

Exclusion Criteria:

• data on ongoing therapy (e.g. lifestyle measures with or without approved drugs), anthropometric or laboratory parameters (including white blood count, estimated glomerular filtration rate, TSH), or REE assessed by the means of indirect calorimetry could not be retrieved
• presenting with conditions known to affect indirect calorimetry (e.g. patients with strenuous exercise on the day before, asymptomatic patients with severe chronic kidney disease (eGFR < 30 ml/min/ 1.73 m2), increased white blood count, or subnormal TSH)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight in Kilograms	Baseline
Neck circumference	Neck circumference in cm	Baseline
Waist circumference	Waist circumference in cm	At baseline
Hip circumference	Hip circumference in cm	Baseline
Body mass index (BMI)	Body mass index (BMI) (expressed in kg/m^2)	At baseline
Resting Energy Expenditure (REE)	Resting Energy Expenditure (REE) in kcal	At baseline

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 6/2020

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