Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00931060
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2009-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'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': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000596', 'term': 'Amino Acids'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial ammonia concentration', 'timeFrame': '1 and 3 hours'}], 'secondaryOutcomes': [{'measure': 'muscle ammonia metabolism', 'timeFrame': '1 hour and 3 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ammonia', 'Citric acid cycle', 'Branched Chain Amino Acids'], 'conditions': ['Liver Diseases', 'Hepatic Encephalopathy', 'Hepatic Insufficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.', 'detailedDescription': 'Branched-chain amino acids (BCAA; leucine, valine, isoleucine) are used to prevent hepatic encephalopathy in cirrhotic patients. The main effect of BCAAs is believed to take place in muscles where BCAAs provide carbon-skeletons for the TCA-cycle. This enhances the conversion of alfa-ketoglutarate to ammonia via glutamine.\n\nWe intend to study the effect of oral administered BCAA on the metabolism of ammonia and amino acids across the leg-muscles by means of catheters inserted into the femoral artery (A) and vein (V). Muscle blood flow (F; L/min) will be determined by constant infusion of indocyanine green and indicator dilution principle. Arterial blood flow and A and V concentrations of ammonia and amino acids will be measured before an oral load of BCAA (0.45 g BCAA/kg body weight) and after 1 and 3 hours. The metabolism of ammonia will also be estimated by means of 13N-NH3 PET scans.\n\nHypothesis: BCAA increases the uptake of ammonia in muscle tissue and lowers arterial ammonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 patients with liver cirrhosis\n* 6 healthy subjects age and sex matched\n\nExclusion Criteria:\n\n* Non-treated diabetes\n* Pregnancy/breast-feeding'}, 'identificationModule': {'nctId': 'NCT00931060', 'briefTitle': 'Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects', 'orgStudyIdInfo': {'id': '15580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Branched chain amino acids', 'description': 'Patients with cirrhosis. Healthy subjects age and sex matched', 'interventionNames': ['Dietary Supplement: Branched chain amino acids']}], 'interventions': [{'name': 'Branched chain amino acids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day', 'armGroupLabels': ['Branched chain amino acids']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susanne Keiding, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gitte Dam', 'oldOrganization': 'PET Centre. Aarhus University Hospital.'}}}}