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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484883
• Other study ID #: 6/2020
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
Italy	National Institute of Gastroenterology IRCCS S. de Bellis	Castellana Grotte	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

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