Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03378375
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2017-12-13
Brief Title:
Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis Creation of a ALS-specific Equation
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis Creation of a ALS-specific Equation
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 WHOFAO 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 10of 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
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 WHOFAO 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 10of 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None