Hypermetabolism in ALS Using Six REE Formulas

NCT ID: NCT03382392

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

449 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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Amyotrophic lateral sclerosis, Resting energy expenditure Predictive equation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ALS

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

Intervention Type OTHER

control 1

No interventions assigned to this group

control 2

No interventions assigned to this group

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Limoges, , France

Site Status

Countries

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France

Other Identifiers

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mREE

Identifier Type: -

Identifier Source: org_study_id