Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-30 @ 11:24 PM
Study NCT ID:
NCT01912235
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2013-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arginine Synthesis in Healthy Adult Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2013-07-26', 'studyFirstSubmitQcDate': '2013-07-30', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Isotope Levels', 'timeFrame': '8 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arginine synthesis', '15N2 arginine, 1-13C Glutamine, 2-15N Glutamine, 15N Proline'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '21677074', 'type': 'RESULT', 'citation': 'Tomlinson C, Rafii M, Ball RO, Pencharz PB. Arginine can be synthesized from enteral proline in healthy adult humans. J Nutr. 2011 Aug;141(8):1432-6. doi: 10.3945/jn.110.137224. Epub 2011 Jun 15.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/21677074', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Arginine synthesis in mammals is a complex process involving at least 8 enzymes and intracellular and interorgan transfer of substrates.\n\nThe investigators have shown in our neonatal studies that there is no conversion of glutamate to arginine but proline label appears in ornithine, citrulline and arginine. It is clear therefore that arginine is synthesized in human neonates from proline.\n\nIn adults the source of the carbon backbone is less clear.', 'detailedDescription': 'Through a series of test in healthy adults using tandem mass spectrometry with carbon labeled GLN and nitrogen labeled PRO to determine the dietary source for the carbon chain of ORN, CIT and ARG. Additionally, using Nitrogen labeled GLN, we will identify the source of the nitrogen atoms in these amino acids.\n\nUsing guanidino - 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine and 15N Proline we will be able to:\n\n1. determine the flux of arginine and proline in healthy adult volunteers\n2. determine and compare the flux of carbon and nitrogen labeled glutamine\n3. demonstrate whether glutamine or proline provides the carbon backbone for ornithine, citrulline and arginine in adults.\n4. the source of the N atoms in ornithine, citrulline and arginine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5 men of average weight 80 kg will be studied\n* healthy, with no know disease of liver, and/or kidney\n* weight stable\n\nExclusion Criteria:\n\n* weith loss or gain over the last three months\n* on medications known to affect amino acid metabolism\n* known liver, kidney disease condition'}, 'identificationModule': {'nctId': 'NCT01912235', 'briefTitle': 'Arginine Synthesis in Healthy Adult Humans', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Arginine Synthesis in Healthy Adult Humans: Does Proline or Glutamate Provide the 5-Carbon Chain?', 'orgStudyIdInfo': {'id': '02/02/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test Study 1: 2-15N glutamine', 'description': 'To determine the contributions make by glutamine to the provision of nitrogen for ornithine, citrulline and arginine syntesis in adults.', 'interventionNames': ['Other: 2-15N glutamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test Study 2: 15N2 arginine &15N proline', 'description': 'administration of 15N2 arginine \\&15N proline to measure arginine and proline flux', 'interventionNames': ['Other: 15N2 arginine and 15N proline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study Test 3: 1-13C glutamine', 'description': 'to determine to contribution of glutamine to the carbon skeleton of ornithine, citrulline and arginine in adults.', 'interventionNames': ['Other: 1-13C glutamine']}], 'interventions': [{'name': '2-15N glutamine', 'type': 'OTHER', 'description': 'Glutamine with N15 isotope tracer', 'armGroupLabels': ['Test Study 1: 2-15N glutamine']}, {'name': '15N2 arginine and 15N proline', 'type': 'OTHER', 'description': 'Arginine and Proline isotope tracers', 'armGroupLabels': ['Test Study 2: 15N2 arginine &15N proline']}, {'name': '1-13C glutamine', 'type': 'OTHER', 'description': 'Glutamine carbon isotope tracer', 'armGroupLabels': ['Study Test 3: 1-13C glutamine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Paul Pencharz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emeritus Scientist', 'investigatorFullName': 'Dr. Paul Pencharz', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}