Sponsors and Collaborators:
Massachusetts General Hospital
National Institutes of Health (NIH)
Information provided by:
National Institute of General Medical Sciences (NIGMS)
This study is currently recruiting patients.
Verified by National Institute of General Medical Sciences (NIGMS) September 2005
Sponsors and Collaborators: Massachusetts General Hospital
National Institutes of Health (NIH)
Information provided by: National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00181753
Purpose
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.
Condition Intervention
Burn Injury
Drug: The "drug" is actually standard vs. glutamine enriched enteral or parenteral feeding formulas.
MedlinePlus related topics: Burns
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
Further study details as provided by National Institute of General Medical Sciences (NIGMS):
Primary Outcomes: This is a nutritional study. The primary outcome is to measure the protein kinetics for metabolism of the amino acid, glutamate and glutamine. Fate will be determine from measurements of subject blood and air samples.
Expected Total Enrollment: 40
Study start: October 2004
Last follow-up: October 2005
We hypothesize that:
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.
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.
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
One or more of the following:
5% Total Body Surface Area Thermal Burn
Inhalation Injury
Resting Energy Expenditure of >15% of the predicted Basal Metabolic Rate Using Harris-Benedict.
Receiving Enteral or Parental Nutritional Support
Exclusion Criteria:
Pre-existing:
Thyroid disease
Congestive Heart Failure (Ejection fraction <20%)
Malignancy currently under treatment
Medical conditions requiring glucocorticoid treatment
Decision not to treat because of severity of injury
Presence of Anoxic brain injury with no expectation for recovery
Self-Inflicted thermal injury
Ileus, gut paralysis, or facial injuries
No NG or OG tube as part of their clinical care
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00181753
Natalie L Harris, BSN nharris@partners.org
Yong Ming Yu, PhD, MD
Massachusetts
Massachusetts General Hospital Burn Unit, Boston, Massachusetts, 02114, United States; Recruiting
Natalie L. Harris, BSN nharris@partners.org
Yong Ming Yu, MD, PhD
John T. Schulz, MD, PhD, Sub-Investigator
Colleen M Ryan, MD, Sub-Investigator
Robert L Sheridan, MD, Sub-Investigator
Study chairs or principal investigators
Ronald G Tompkins, MD, ScD, Principal Investigator, MGH, Shriners Burn Hospital-Boston
More Information
Study ID Numbers: 2P50 GM021700-27A1; 2004-P-001946
Last Updated: March 27, 2006
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00181753
Health Authority: United States: Institutional Review Board; United States: Federal Government
ClinicalTrials.gov processed this record on 2006-11-17
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Massachusetts General Hospital
National Institutes of Health (NIH)
Information provided by:
National Institute of General Medical Sciences (NIGMS)
This study is currently recruiting patients.
Verified by National Institute of General Medical Sciences (NIGMS) September 2005
Sponsors and Collaborators: Massachusetts General Hospital
National Institutes of Health (NIH)
Information provided by: National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00181753
Purpose
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.
Condition Intervention
Burn Injury
Drug: The "drug" is actually standard vs. glutamine enriched enteral or parenteral feeding formulas.
MedlinePlus related topics: Burns
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
Further study details as provided by National Institute of General Medical Sciences (NIGMS):
Primary Outcomes: This is a nutritional study. The primary outcome is to measure the protein kinetics for metabolism of the amino acid, glutamate and glutamine. Fate will be determine from measurements of subject blood and air samples.
Expected Total Enrollment: 40
Study start: October 2004
Last follow-up: October 2005
We hypothesize that:
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.
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.
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
One or more of the following:
5% Total Body Surface Area Thermal Burn
Inhalation Injury
Resting Energy Expenditure of >15% of the predicted Basal Metabolic Rate Using Harris-Benedict.
Receiving Enteral or Parental Nutritional Support
Exclusion Criteria:
Pre-existing:
Thyroid disease
Congestive Heart Failure (Ejection fraction <20%)
Malignancy currently under treatment
Medical conditions requiring glucocorticoid treatment
Decision not to treat because of severity of injury
Presence of Anoxic brain injury with no expectation for recovery
Self-Inflicted thermal injury
Ileus, gut paralysis, or facial injuries
No NG or OG tube as part of their clinical care
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00181753
Natalie L Harris, BSN nharris@partners.org
Yong Ming Yu, PhD, MD
Massachusetts
Massachusetts General Hospital Burn Unit, Boston, Massachusetts, 02114, United States; Recruiting
Natalie L. Harris, BSN nharris@partners.org
Yong Ming Yu, MD, PhD
John T. Schulz, MD, PhD, Sub-Investigator
Colleen M Ryan, MD, Sub-Investigator
Robert L Sheridan, MD, Sub-Investigator
Study chairs or principal investigators
Ronald G Tompkins, MD, ScD, Principal Investigator, MGH, Shriners Burn Hospital-Boston
More Information
Study ID Numbers: 2P50 GM021700-27A1; 2004-P-001946
Last Updated: March 27, 2006
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00181753
Health Authority: United States: Institutional Review Board; United States: Federal Government
ClinicalTrials.gov processed this record on 2006-11-17
Chiama questi istituti e digli che tu ne sai più di loro, non c'è dubbio, potresti aiutare tantissima gente invece di stare qui a replicare...
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