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Completed

NCT Number: NCT03382392

Hypermetabolism in ALS Using Six REE Formulas

Introduction: About 50-60% of Amyotrophic Lateral Sclerosis (ALS) is characterized by hypermetabolism, defined as 10% or more excess resting energy expenditure (REE) compared to theoretical values. Harris and Benedict's (HB) formula is the equation mainly used to predict REE, but others are also applied in current practice. The present study aimed to assess REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

Nutritional assessments were performed in ALS patients and in two control populations without hypermetabolism: healthy elderly people (control 1) and patients with non-restrictive-eating disorders (control 2). Weight, height and body composition (by bioimpedance analysis) were assessed.

EE was measured (mREE) by indirect calorimetry and calculated (cREE) using HB 1919 and 1984, World Schofield, De Lorenzo, Johnstone and Mifflin formulas. Mann-Whitney and Chi2 tests were used to compare the equations.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Limoges, 87 042, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ALS patients
  • 18 years old or more
  • IC and nutritional assessment within 1.5 months
  • delay between diagnosis and IC < 12 months

Exclusion criteria

-

Treatment and study plan

Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

Other

Primary outcomes

  1. Measure of REE

    Time frame: indirect calorimetry (IC) and nutritional assessment within 1.5 months, and diagnosis and IC within 12 months

    EE was measured (mREE) by indirect calorimetry and calculated (cREE) using Harris and Benedict's (HB) formula

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

Increased Resting Energy Expenditure Compared to Six Predictive Theoretical Equations in Amyotrophic Lateral Sclerosis: a Study Versus Controls

Important dates

Study start
1996
Primary completion
2014
Study completion
2014
First posted
Dec 22, 2017
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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