Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181753
Status:
WITHDRAWN
Last Update Posted:
2017-01-13
First Post:
2005-09-13
Brief Title:
Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
Sponsor:
Massachusetts General Hospital
Organization:
National Institute of General Medical Sciences NIGMS
Study Overview
Official Title:
Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
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WITHDRAWN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State of Mass tightened regulations for making intravenous solutions for research subjects Study was withdrawn and no participants were enrolled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 purpose of the study is to understand how the body uses amino acids in burned patients during the time they cannot eat normally Amino acids occur naturally in the body and the food we eat The body combines amino acids to make protein It uses the proteins to do things such as heal wounds fight infection and provide energy We are studying two ways of receiving nutrition through a vein or through a tube We are also studying two different types of food with or without glutamine The results of this study will be used to determine the best type and way to supply nutrients during a severe burn injury We hope to learn how to help the body use nutrients more efficiently to better repair wounded tissues and recover earlier from injury
Detailed Description:
We hypothesize that
1 Burn patients will experience an increased conversion of glutamine to glutamate and a decreased conversion of glutamate to glutamine as compared to healthy subjects The net direction is from glutamine to glutamate in burn patients and would render glutamine as a conditionally essential amino acid
2 Because of the limited ability of liver to oxidize glutamate it is possible that large doses of glutamine may cause increased gluconeogenesis in burn patients thus aggravating the glucose homeostasis secondary to insulin resistance
3 Enterally and parenterally fed glutamine and glutamate have different metabolic fate in the splanchnic bed and peripheral regions therefore the doses should be tailored according to the route of administration
This study using stable isotope tracers aims to track the metabolic fate of glutamine and glutamate in body with the goal of enhancing nutritional efficiency
1 Burn patients will experience an increased conversion of glutamine to glutamate and a decreased conversion of glutamate to glutamine as compared to healthy subjects The net direction is from glutamine to glutamate in burn patients and would render glutamine as a conditionally essential amino acid
2 Because of the limited ability of liver to oxidize glutamate it is possible that large doses of glutamine may cause increased gluconeogenesis in burn patients thus aggravating the glucose homeostasis secondary to insulin resistance
3 Enterally and parenterally fed glutamine and glutamate have different metabolic fate in the splanchnic bed and peripheral regions therefore the doses should be tailored according to the route of administration
This study using stable isotope tracers aims to track the metabolic fate of glutamine and glutamate in body with the goal of enhancing nutritional efficiency
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 |
|---|---|---|---|
| 2004-P-001946 | None | None | None |