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Completed

NCT Number: NCT04484883

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, 70013, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Observational

Other

Observational

Other names: Retrospective cohort study

Primary outcomes

  1. Body weight

    Time frame: Baseline

    Body weight in Kilograms

  2. Neck circumference

    Time frame: Baseline

    Neck circumference in cm

  3. Waist circumference

    Time frame: At baseline

    Waist circumference in cm

  4. Hip circumference

    Time frame: Baseline

    Hip circumference in cm

  5. Body mass index (BMI)

    Time frame: At baseline

    Body mass index (BMI) (expressed in kg/m^2)

  6. Resting Energy Expenditure (REE)

    Time frame: At baseline

    Resting Energy Expenditure (REE) in kcal

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2020
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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