Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Massachusetts General Hospital National Institutes of Health (NIH) |
---|---|
Information provided by: | National Institute of General Medical Sciences (NIGMS) |
ClinicalTrials.gov Identifier: | NCT00217035 |
Proline is a non-essential amino acid that helps with collagen formation. Collagen is one of the main ingredients of skin, bone, tendons, and connective tissue. It is thought that proline becomes depleted in burn patients because it is being used in greater than normal quantities to help the injured skin and connective tissue heal. If this is true, then the body must look for alternate energy sources as proline becomes depleted.
This study aims to evaluate 1)the metabolic kinetics of the amino acids proline, glutamate, and ornithine and 2) the effects of glutamine supplemented total parenteral nutrition (TPN) on the metabolism of these amino acids.
Condition | Intervention |
---|---|
Burns |
Dietary Supplement: TPN or TPN enriched with glutamine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients. |
Estimated Enrollment: | 16 |
Study Start Date: | August 1997 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: No Intervention
To study proline balance; the quantitative relationships among proline, ornithine and glutamate with an emphasis on evaluating the rate of proline disposal and conversion to ornithine and glutamate in burn patients.
|
Dietary Supplement: TPN or TPN enriched with glutamine
Each patient undergoes two nutritional support periods either with or without Glutamine supplementation.
|
2: No Intervention
This study serves the purpose of evaluating the conversion rate of ornithine and glutamate to proline and the rate of proline de novo synthesis using stable isotopic tracers.
|
Proline is a nutritionally dispensable (non-essential) amino acid. Its synthesis and catabolism is via the pathway of ornithine and glutamate. The latter two amino acids serve as immediate precursors for proline, as well as metabolites. Ornithine is one of the intermediates for urea cycle. 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. We further propose that increased supply of glutamine would increase the de novo synthesis of proline and / or spare the loss of proline via its metabolite glutamate. Hence, glutamine will be beneficial to the overall nutritional status of the burn patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Burn patients being treated at MGH Burn Unit with one or more of the following criteria: 1) >=5% TBSA; 2) inhalation injury; or 3) resting energy expenditure (REE) of >15% of the predicted Basal Metabolic Rate using the Harris-Benedict equation.
Must be receiving total parenteral nutrition in the course of their treatment.
Exclusion Criteria:
Patients with thyroid disease. Patients who are not hemodynamically stable or show unstable vital signs Patients at the stage of major organ failure, e.g. renal and/or liver failure.
Contact: Mary-Liz C Bilodeau, MS | 617-726-8766 | mbilodeau@partners.org |
Contact: Yong-Ming Yu, PhD, MD |
United States, Massachusetts | |
Massachusetts General Hospital Burn Unit | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Sub-Investigator: Robert L Sheridan, MD | |
Sub-Investigator: Shawn P Fagan, MD | |
Sub-Investigator: Colleen M Ryan, MD | |
Sub-Investigator: Yong-Ming Yu, MD, PhD |
Principal Investigator: | Ronald G Tompkins, MD, ScD | MGH, Shriners Burn Hospital - Boston |
Responsible Party: | Massachusetts General Hospital ( Ronald G. Tompkins, MD, ScD, Chief, Burn Service ) |
Study ID Numbers: | 1999-P-008462, 2P50 GM021700-27 |
Study First Received: | September 19, 2005 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00217035 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
parenteral nutrition burn injury stable isotopes Proline Metabolic Kinetics |
Ornithine Metabolic Kinetics Glutamate Metabolic Kinetics Glutamine Metabolic Kinetics |
Burns |