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NCT03382392 Clinical Trial

Hypermetabolism in ALS Using Six REE Formulas

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03382392
Other study ID # mREE
Secondary ID
Status Completed
Phase N/A
First received December 13, 2017
Last updated December 21, 2017
Start date November 1996
Est. completion date November 2014

Study information
Verified date December 2017
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 449
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of REE EE was measured (mREE) by indirect calorimetry and calculated (cREE) using Harris and Benedict's (HB) formula indirect calorimetry (IC) and nutritional assessment within 1.5 months, and diagnosis and IC within 12 months
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