Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT00217035
Status:
WITHDRAWN
Last Update Posted:
2017-01-13
First Post:
2005-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}, {'id': 'D018529', 'term': 'Nutritional Support'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'State of Mass. tightened regulations for making intravenous solutions for research subjects. Study was withdrawn and no participants were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '1997-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2005-09-19', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This is a study for measuring the protein kinetics for metabolism of the amino acids proline, glutamate, and ornithine. Kinetics will be derived from measurements on blood and air samples taken as part of the study.', 'timeFrame': '12 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['parenteral nutrition', 'burn injury', 'stable isotopes', 'Proline Metabolic Kinetics', 'Ornithine Metabolic Kinetics', 'Glutamate Metabolic Kinetics', 'Glutamine Metabolic Kinetics'], 'conditions': ['Burns']}, 'referencesModule': {'references': [{'pmid': '18590940', 'type': 'BACKGROUND', 'citation': 'Tharakan JF, Yu YM, Zurakowski D, Roth RM, Young VR, Castillo L. Adaptation to a long term (4 weeks) arginine- and precursor (glutamate, proline and aspartate)-free diet. Clin Nutr. 2008 Aug;27(4):513-22. doi: 10.1016/j.clnu.2008.04.014. Epub 2008 Jun 30.'}, {'pmid': '11171607', 'type': 'BACKGROUND', 'citation': 'Yu YM, Ryan CM, Castillo L, Lu XM, Beaumier L, Tompkins RG, Young VR. Arginine and ornithine kinetics in severely burned patients: increased rate of arginine disposal. Am J Physiol Endocrinol Metab. 2001 Mar;280(3):E509-17. doi: 10.1152/ajpendo.2001.280.3.E509.'}, {'pmid': '8289668', 'type': 'BACKGROUND', 'citation': 'Castillo L, Ajami A, Branch S, Chapman TE, Yu YM, Burke JF, Young VR. Plasma arginine kinetics in adult man: response to an arginine-free diet. Metabolism. 1994 Jan;43(1):114-22. doi: 10.1016/0026-0495(94)90166-x.'}, {'pmid': '1858705', 'type': 'BACKGROUND', 'citation': 'Jaksic T, Wagner DA, Burke JF, Young VR. Proline metabolism in adult male burned patients and healthy control subjects. Am J Clin Nutr. 1991 Aug;54(2):408-13. doi: 10.1093/ajcn/54.2.408.'}, {'pmid': '3670073', 'type': 'BACKGROUND', 'citation': 'Jaksic T, Wagner DA, Burke JF, Young VR. Plasma proline kinetics and the regulation of proline synthesis in man. Metabolism. 1987 Nov;36(11):1040-6. doi: 10.1016/0026-0495(87)90023-0.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBurn 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.\n\nMust be receiving total parenteral nutrition in the course of their treatment.\n\nExclusion Criteria:\n\nPatients 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.'}, 'identificationModule': {'nctId': 'NCT00217035', 'briefTitle': 'Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients', 'organization': {'class': 'NIH', 'fullName': 'National Institute of General Medical Sciences (NIGMS)'}, 'officialTitle': 'Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients.', 'orgStudyIdInfo': {'id': '1999-P-008462'}, 'secondaryIdInfos': [{'id': '2P50GM021700-27', 'link': 'https://reporter.nih.gov/quickSearch/2P50GM021700-27', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'TPN or TPN enriched with glutamine', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutritional Support', 'Amino Acid Composition'], 'description': 'Each patient undergoes two nutritional support periods either with or without Glutamine supplementation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Burn Unit', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ronald G Tompkins, MD, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MGH, Shriners Burn Hospital - Boston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Ronald G. Tompkins, MD, ScD, Chief, Burn Service', 'oldOrganization': 'Massachusetts General Hospital'}}}}