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

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Other: nutritional assessement

• Study Type: Observational
• Enrollment (Actual): 315

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • CHU Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ALS diagnosed patients according to Airlie House criteria

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Resting energy expenditure emeasures	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.

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 1996
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: ALS/jesus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No