Quantitative Measurement of Nutritional Substrate Utilization in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT00714220 | Terminated

• 1 other identifier: Internal-16684
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The work of Nau et. al (Nau KL, Bromberg MB, Forshew DA, Katcha Vl. Individuals with amyotrophic lateral sclerosis are in caloric balance despite losses in mass. J Neurol Sci 1995;129 :47-49) showed that patients in the early stages of ALS initially increase their body fat. Another study showed that advanced ALS patients on mechanical ventilation were actually hypometabolic, supporting a hypothesis that ALS patients' daily oral intakes of calories fail to match their energy requirements, thus exacerbating their condition. This current study investigates and compares substrate utilization using a metabolic cart in controls and in ALS patients who are on and off ventilatory support to examine differences in substrate utilization between the two groups of ALS patients and the controls. (Substrate utilization is essentially the percentage of fats, carbohydrates, and protein utilized by the body.) The study will increase our understanding of the nutritional needs of ALS patients and improve our ability to provide the best possible nutrition in progressive illness.

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases

Keywords

Amyotrophic Lateral Sclerosis; Gastric Motility; Autonomic Nervous System; Neurodegenerative Diseases; Movement Disorders; Substrate Utilization

Outcome Measures

Primary Outcomes (1)

• Indirect Calorimetry

  Indirect calorimetry will be used to determine how many calories you are burning and how much of your total calories burned are fats.

  20 minute session

Study Arms (3)

ALS

Subjects having either definite or probable ALS by El Escorial Criteria.

Neurological Control

Subjects having been diagnosed with a non-ALS neurological condition

Healthy Control

Subjects in good health without any neurological conditions

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS clinic patients at MDA/ALS Center of Hope.

You may qualify if:

• Diagnosis of definite or possible ALS by the El Escorial Criteria
• No previously known gastrointestinal problems

You may not qualify if:

• Patients or controls who have evidence of previous gastrointestinal disease
• Patients unable to give informed consent

Sponsors & Collaborators

• Drexel University College of Medicine: lead
• MDA/ALS Center of Hope: collaborator

Study Sites (1)

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Movement Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: November 1, 2006
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

US (1)