Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation
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|ClinicalTrials.gov Identifier: NCT03378375|
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Amyotrophic Lateral Sclerosis||Other: nutritional assessement|
|Study Type :||Observational|
|Actual Enrollment :||315 participants|
|Official Title:||Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation|
|Actual Study Start Date :||November 1996|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
- Resting energy expenditure emeasures [ Time Frame: 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. ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378375
|Limoges, France, 87042|