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Hypermetabolism in ALS Using Six REE Formulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03382392
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

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.


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

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Study Type : Observational
Actual Enrollment : 449 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Increased Resting Energy Expenditure Compared to Six Predictive Theoretical Equations in Amyotrophic Lateral Sclerosis: a Study Versus Controls
Actual Study Start Date : November 1996
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


Group/Cohort Intervention/treatment
ALS Other: Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.
control 1
control 2



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
ALS patients
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382392


Locations
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France
Limoges, France, 87 042
Sponsors and Collaborators
University Hospital, Limoges

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03382392    
Other Study ID Numbers: mREE
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Amyotrophic lateral sclerosis,
Resting energy expenditure
Predictive equation
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases