Hypermetabolism in ALS Using Six REE Formulas

• Sponsor: University Hospital, Limoges (Other)
• Overall Status: Completed
• CT.gov ID: NCT03382392
• Collaborator: (none)
• Enrollment: 449
• Location: 1
• Actual Duration (Months): 216
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	Phase
Amyotrophic Lateral Sclerosis	Other: Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

Study Design

• 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: Nov 1, 1996
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Measure of REE [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Limoges		France	87 042

Sponsors and Collaborators

• University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Limoges
• ClinicalTrials.gov Identifier: NCT03382392
• Other Study ID Numbers: mREE
• First Posted: Dec 22, 2017
• Last Update Posted: Dec 22, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis

Study Results

No Results Posted as of Dec 22, 2017