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临床试验/NCT04484883
NCT04484883已完成不适用

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

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
1
主要终点
Waist circumference

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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)

结局指标

主要结局

Waist circumference

时间窗: At baseline

Waist circumference in cm

Body mass index (BMI)

时间窗: At baseline

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

Resting Energy Expenditure (REE)

时间窗: At baseline

Resting Energy Expenditure (REE) in kcal

Neck circumference

时间窗: Baseline

Neck circumference in cm

Body weight

时间窗: Baseline

Body weight in Kilograms

Hip circumference

时间窗: Baseline

Hip circumference in cm

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluigi Giannelli

Clinical Professor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

研究点 (1)

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