Ignite Creation Date:
2024-05-05 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00714220
Status:
TERMINATED
Last Update Posted:
2015-10-29
First Post:
2008-07-10
Brief Title:
Quantitative Measurement of Nutritional Substrate Utilization in Patients With Amyotrophic Lateral Sclerosis ALS
Sponsor:
Drexel University College of Medicine
Organization:
Drexel University
Study Overview
Official Title:
Quantitative Measurement of Nutritional Substrate Utilization in Patients With ALS
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding and support staff
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1995129 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 patients VCO2 and VO2 will be measured - as the patient breaths into a mask connected to the machine- RQ will be calculated using Lavoisier and Laplaces equation RQ VCO2VO2
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 5925L of oxygen and produces 475L 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 72 Non-Protein Respiratory Quotient And The Relative Quantity Of Carbohydrate And Fat Oxidized And Energy Per Liter Of Oxygen Appendix-Iv 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
PCR24hr UUNg 4 x 625 gday 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
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 patients VCO2 and VO2 will be measured - as the patient breaths into a mask connected to the machine- RQ will be calculated using Lavoisier and Laplaces equation RQ VCO2VO2
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 5925L of oxygen and produces 475L 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 72 Non-Protein Respiratory Quotient And The Relative Quantity Of Carbohydrate And Fat Oxidized And Energy Per Liter Of Oxygen Appendix-Iv 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
PCR24hr UUNg 4 x 625 gday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None