Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216983
Status:
WITHDRAWN
Last Update Posted:
2017-01-13
First Post:
2005-09-20
Brief Title:
Proline Metabolism in Severely Burned Patients Effect of Modulated Parenteral Feeding
Sponsor:
Massachusetts General Hospital
Organization:
National Institute of General Medical Sciences NIGMS
Study Overview
Official Title:
Proline Metabolism in Severely Burned Patients Effect of Modulated Parenteral Feeding
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
State of Mass tightened regulations for making intravenous solutions for research subjects Study was withdrawn and no participants were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall purpose of the study is to evaluate the effect of depleting proline supply in the nutritional support regimen on proline metabolism in the burn patients this includes the rate of proline oxidation after burn injury the rate of proline de novo synthesis from its immediate precursors glutamate and ornithine The specific aims of the proposed study are 1 to determine the kinetic status of proline metabolism and whole body proline balance under the following nutritional states a fasting b regular total parenteral nutrition TPN cTPN with isonitrogenous depletion of proline glutamate and ornithine metabolism under nutritional conditions studied in specific aim 1 above
Detailed Description:
Proline is a non-essential amino acid Its synthesis and catabolism is via the pathway of ornithine and glutamate the latter two amino acids serve as its immediate precursors as well as metabolites Ornithine is one of the intermediates for urea cycle and glutamate is metabolically connected to tricarboxylic acid TCA cycle the major cycle for energy production
It is hypothesized that the significantly increased rates of net nitrogen loss and energy production as the consequence of the accelerated activities of both the urea and TCA cycles in burn injury drain both ornithine and glutamate thus depleting tissues of the availability of proline Hence the de novo synthesis of proline is likely to be affected by the reduced availability of its major precursors glutamate and ornithine
This hypothesis is supported by 1 tissue and circulating glutamine content are reduced in stressed conditions 2 ornithine disposal via oxidation is significantly increased after burn injury2 Therefore the availability of proline is likely to be limiting after burn injury for the synthesis of proteins On the other hand proline requirement is significantly increased in burn patients due to the high demand for tissue repair and wound healing As a result providing an adequate proportion of its precursors glutamine glutamate and or as preformed proline is of importance to maintain the appropriate supply and balance of amino acids for protein and other synthetic functions after burn injury
The overall purpose of the study is to evaluate the effect of depleting proline supply in the nutritional support regimen on proline metabolism in the burn patients this includes the rate of proline oxidation after burn injury the rate of proline de novo synthesis from its immediate precursors glutamate and ornithine The specific aims of the proposed study are 1 to determine the kinetic status of proline metabolism and whole body proline balance under the following nutritional states a fasting b regular total parenteral nutrition TPN cTPN with isonitrogenous depletion of proline glutamate and ornithine metabolism under nutritional conditions studied in specific aim 1 above
It is hypothesized that the significantly increased rates of net nitrogen loss and energy production as the consequence of the accelerated activities of both the urea and TCA cycles in burn injury drain both ornithine and glutamate thus depleting tissues of the availability of proline Hence the de novo synthesis of proline is likely to be affected by the reduced availability of its major precursors glutamate and ornithine
This hypothesis is supported by 1 tissue and circulating glutamine content are reduced in stressed conditions 2 ornithine disposal via oxidation is significantly increased after burn injury2 Therefore the availability of proline is likely to be limiting after burn injury for the synthesis of proteins On the other hand proline requirement is significantly increased in burn patients due to the high demand for tissue repair and wound healing As a result providing an adequate proportion of its precursors glutamine glutamate and or as preformed proline is of importance to maintain the appropriate supply and balance of amino acids for protein and other synthetic functions after burn injury
The overall purpose of the study is to evaluate the effect of depleting proline supply in the nutritional support regimen on proline metabolism in the burn patients this includes the rate of proline oxidation after burn injury the rate of proline de novo synthesis from its immediate precursors glutamate and ornithine The specific aims of the proposed study are 1 to determine the kinetic status of proline metabolism and whole body proline balance under the following nutritional states a fasting b regular total parenteral nutrition TPN cTPN with isonitrogenous depletion of proline glutamate and ornithine metabolism under nutritional conditions studied in specific aim 1 above
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2P50GM021700-27 | NIH | None | httpsreporternihgovquickSearch2P50GM021700-27 |