Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT01774994
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2013-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-23', 'studyFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'whole body NO synthesis', 'timeFrame': '2 hours', 'description': 'postabsorptive nitric oxide synthesis measured by using stable isotope methodology'}], 'secondaryOutcomes': [{'measure': 'whole body protein metabolism', 'timeFrame': '2 hours', 'description': 'postabsorptive whole body protein metabolism (protein synthesis, breakdown, net protein breakdown) measured by using stable isotope methodology'}, {'measure': 'whole body arginine metabolism', 'timeFrame': '2 hours', 'description': 'postabsorptive arginine metabolism measured by using stable isotope methodology'}, {'measure': 'blood parameters', 'timeFrame': '2 hours', 'description': 'postabsorptive blood levels (glucose, insulin, urea, amino acids, CRP)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23011059', 'type': 'BACKGROUND', 'citation': 'Luiking YC, Ten Have GA, Wolfe RR, Deutz NE. Arginine de novo and nitric oxide production in disease states. Am J Physiol Endocrinol Metab. 2012 Nov 15;303(10):E1177-89. doi: 10.1152/ajpendo.00284.2012. Epub 2012 Sep 25.'}, {'pmid': '19841582', 'type': 'BACKGROUND', 'citation': 'Luiking YC, Engelen MP, Deutz NE. Regulation of nitric oxide production in health and disease. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):97-104. doi: 10.1097/MCO.0b013e328332f99d.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of arginine and NO metabolism in healthy subjects is important as a reference for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate the changes during aging and gender-related differences. Although data on arginine metabolism exist in literature, data are limited to young healthy male subjects. Since patients with suspected changes in arginine metabolism, e.g. sepsis and cancer patients are often elderly and also women, knowledge of arginine metabolism in these groups is needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age 18-25 years (young); 50-70 years (middle aged/elderly)\n\nExclusion Criteria:\n\n* Diabetes mellitus type I\n* Livercirrhosis, pancreatitis, malignancies\n* Hypertension (diastolic blood pressure \\>95 mmHg or systolic blood pressure \\>160 mmHg)\n* History of gastrointestinal complaints\n* Recent involuntary weight loss (more than 10 % in 6 months or more than 5 % in one month)\n* Pregnancy (pregnancy test is done in female subjects)\n* Use of medication that can affect arginine metabolism (nitrovasodilators and corticosteroids)\n* Subjects with "high activity level"'}, 'identificationModule': {'nctId': 'NCT01774994', 'briefTitle': 'Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers', 'orgStudyIdInfo': {'id': 'MEC04-021.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stable isotopes', 'description': 'stable isotope infusion for measurement of metabolism', 'interventionNames': ['Other: stable isotope infusion for measurement of metabolism']}], 'interventions': [{'name': 'stable isotope infusion for measurement of metabolism', 'type': 'OTHER', 'armGroupLabels': ['stable isotopes']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicolaas E Deutz, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}