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临床试验/NCT03378375
NCT03378375已完成不适用

Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation

University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 1996年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
315
试验地点
1
主要终点
Resting energy expenditure emeasures

研究概览

简要总结

Introduction: Resting energy expenditure (REE) formulas for healthy people (HP) are used to calculate REE (cREE) in amyotrophic lateral sclerosis (ALS) patients. In ALS an increase of measured REE (mREE) in indirect calometry (IC) compared to cREE is found in 50-60%. The aims were (i) to assess accuracy of cREE assessed using eleven formulas as compared to mREE and (ii) to create if needed a specific cREE formula for ALS patients.

Method: ALS patients followed in the ALS expert center of Limoges between 1996 and 2014 and with a nutritional evaluation were included. mREE assessed with IC and cREE calculated with eleven predictive formulas (Harris Benedict (HB) 1919, HB 1984, WSchofield, De Lorenzo, Johnstone, Mifflin, WHO/FAO, Owen, Fleisch, Wang and Rosenbaum) were collected at time of diagnosis. Fat free mass (FFM) and fat mass (FM) were measured with impedancemetry. A Bland and Altman analysis was carried out. The percentage of accurate prediction ± 10%of mREE, and intraclass correlation coefficients (ICC) were calculated. Using a derivation sample, a new REE formula was created using multiple linear regression according to sex, age, FFM and FM. Accuracy of this formula was assessed in a validation sample.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ALS diagnosed patients according to Airlie House criteria
  • treated with riluzole
  • respiratory quotient (RQ) of patients in indirect calorimetry (IC) should be in between 0.7 and 0.87

排除标准

  • 未提供

结局指标

主要结局

Resting energy expenditure emeasures

时间窗: nutritional assessement should have been be performed within a 1.5 months' time period. IC had to be performed no later than 12 months after diagnosis.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (1)

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