Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00714220
Recruitment Status : Terminated (Lack of funding and support staff.)
First Posted : July 14, 2008
Last Update Posted : October 29, 2015
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )

Tracking Information
First Submitted Date July 10, 2008
First Posted Date July 14, 2008
Last Update Posted Date October 29, 2015
Study Start Date November 2006
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2013)
Indirect Calorimetry [ Time Frame: 20 minute session ]
Indirect calorimetry will be used to determine how many calories you are burning and how much of your total calories burned are fats.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quantitative Measurement of Nutritional Substrate Utilization in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title Quantitative Measurement of Nutritional Substrate Utilization in Patients With ALS
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.
Detailed Description

Study groups will include ALS patients with and without respiratory failure as judged by their FVC and use of either noninvasive or invasive ventilation along with normal controls. For all patients, nutritional status will be assessed by measurement of weight, and determination of Urinary Urea Nitrogen (via 24hr urinary sample), albumin and pre-albumin levels and questions regarding recent weight changes. In addition, for ALS patients, clinical data regarding the age of the patient, duration of disease, site of onset along with ALS-FRS (Amyotrophic Lateral Sclerosis Functional Rating Scale) and Pulmonary function testing will be collected. If these data are already available from chart as they are commonly performed during routine care, the data will be obtained from the patients chart.

5cc blood will be obtained for measurement of Serum albumin, pre-albumin and TNF-α. Antigenic TNF-α, bioactive TNF-α and receptors serum sTNF-RI and TNF-RII will be measured using the standard ELISA kits and cytolytic assays.

Respiratory Quotients (RQs) will be measured using a metabolic cart in both controls and ALS patients. First, the patient's VCO2 and VO2 will be measured - as the patient breaths into a mask connected to the machine.- RQ will be calculated using Lavoisier and Laplace's equation: RQ = VCO2/VO2.

This, however, is not an accurate representation because it considers only fats and carbohydrates as the sources for these gases. A corrected Non-Protein RQ (NPRQ) RQ will be calculated using a 24 hour urine sample and measuring the Urinary Urea Nitrogen (24hr UUN). This tells us the amount of protein oxidized per 24 hours. Then, applying the principle that one gram of urinary nitrogen represents the combustion of an amount of protein that requires 5.925L of oxygen and produces 4.75L of carbon dioxide, the amount of oxygen and carbon dioxide associated with protein metabolism will be calculated. This calculated VO2 and VCO2 will then be subtracted from the totals measured using the metabolic cart and the corrected Non-Protein RQ will be calculated.

The corrected respiratory quotient will then be used to calculate the amount of nutritional substrate utilization in the patient population using Table 7.2. Non-Protein Respiratory Quotient And The Relative Quantity Of Carbohydrate And Fat Oxidized And Energy Per Liter Of Oxygen (Appendix-I).v The amount (grams) of carbohydrate and fats utilized per each NPRQ will be recorded.

The protein catabolic rate (PCR) will also be calculated using the equation :

PCR=[24hr UUN(g) + 4] x 6.25 (g/day). The clinical information along with test results will be collected in a spreadsheet in which patients and controls are de-identified. This spreadsheet will be used for the analysis.

Primary endpoints are the analysis of nutritional substrate utilization with and without respiratory compromise. Secondary endpoints include the correlation of in the composition of substrate utilization between patients who use a ventilator and those who do not, those patients with and without a PEG Tube in each group, and correlation of substrate use with the stage of illness as judged by the ALSFRS score, weight changes and duration of disease.

This is a one time testing procedure, and the patient will not be asked to return back for another visit.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ALS clinic patients at MDA/ALS Center of Hope.
Condition
  • Amyotrophic Lateral Sclerosis
  • Neurodegenerative Diseases
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 1, 2014)
107
Original Estimated Enrollment
 (submitted: July 10, 2008)
90
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients or controls who have evidence of previous gastrointestinal disease
  • Patients unable to give informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00714220
Other Study ID Numbers Internal-16684
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Drexel University ( Drexel University College of Medicine )
Study Sponsor Drexel University College of Medicine
Collaborators MDA/ALS Center of Hope
Investigators Not Provided
PRS Account Drexel University
Verification Date October 2015