Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT01002469
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2009-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056806', 'term': 'Urea Cycle Disorders, Inborn'}], 'ancestors': [{'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012964', 'term': 'Sodium'}, {'id': 'D000085', 'term': 'Acetates'}], 'ancestors': [{'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-14', 'studyFirstSubmitDate': '2009-10-26', 'studyFirstSubmitQcDate': '2009-10-26', 'lastUpdatePostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline'}], 'secondaryOutcomes': [{'measure': 'Cmax of absolute [13C]urea in plasma'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['isotope ratio measurement', 'urea cycle', '13C acetate', 'Healthy adults'], 'conditions': ['Urea Cycle Disorders']}, 'descriptionModule': {'briefSummary': 'In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for patients with urea cycle disorders and to monitor the severity of the disease, a reliable and safe quantitative method for the measurement of the urea cycle flux is required.\n\nUrea synthesis will be evaluated by administering sodium \\[1-13C\\]-acetate and measuring subsequent incorporation of \\[13C\\] label from Na-acetate into urea in healthy volunteers and asymptomatic subjects genetically disposed to urea cycle disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1 + 2: Healthy subjects\n* Group 3: Healthy asymptomatic subjects genetically disposed to urea cycle disorders\n* All: age 18 to 50 years (adult)\n* Written informed consent\n\nExclusion Criteria:\n\n* Presence of acute infection\n* Participation in other clinical trials within 30 days prior to inclusion\n* Severe coagulopathy\n* Severe systemic or chronic disease\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01002469', 'briefTitle': 'Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytonet GmbH & Co. KG'}, 'officialTitle': 'Pilot Feasibility Study in Healthy Subjects and Healthy Asymptomatic Subjects Genetically Disposed to Urea Cycle Disorders to Evaluate the Use of 13 C Isotope Ratio Measurement', 'orgStudyIdInfo': {'id': 'CCD07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sodium [1-13C] acetate', 'interventionNames': ['Other: sodium [1-13C] acetate']}], 'interventions': [{'name': 'sodium [1-13C] acetate', 'type': 'OTHER', 'armGroupLabels': ['sodium [1-13C] acetate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41061', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'CRS Clinical Research Services Mönchengladbach GmbH', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}], 'overallOfficials': [{'name': 'Doris Neuenhofer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRS Clinical Research Services Mönchengladbach GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytonet GmbH & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Heinz Kriegbaum', 'oldOrganization': 'Cytonet GmbH & Co. KG'}}}}