Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT06645769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2024-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Na-Phenylbutyrate VAscular Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075773', 'term': '4-phenylbutyric acid'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Home ambulatory mean pressure and pulse pressure', 'timeFrame': 'from enrollment to the end of participation at 8 weeks', 'description': 'At home blood pressure cuff used to determine changes in blood pressure with normal activities (mmHg)'}, {'measure': 'Cardiac Ejection Fraction', 'timeFrame': 'from enrollment to the end of participation at 8 weeks', 'description': 'echocardiography will be used to determine ejection fraction (%)'}], 'primaryOutcomes': [{'measure': 'Systemic vascular resistance', 'timeFrame': 'from enrollment to the end of participation at 8 weeks', 'description': 'Arterial hemodynamics and echocardiography to assess systemic vascular resistance, in dynes × sec/cm5.'}], 'secondaryOutcomes': [{'measure': 'Plasma BCAAs', 'timeFrame': 'from enrollment to the end of participation at 8 weeks', 'description': 'Plasma branched chain amino acid levels, measured by mass spectrometry (in microMolar)'}, {'measure': 'Flow-mediated dilation (FMD)', 'timeFrame': 'from enrollment to the end of participation at 8 weeks', 'description': 'FMD is a non-invasive test that measures the endothelial function of blood vessels. FMD is measured as a percentage increase in the diameter of an artery during hyperemia (%).'}, {'measure': 'Carotid femoral pulse wave velocity (PWV)', 'timeFrame': 'from enrollment to the end of participation at 8 weeks', 'description': 'Pulse wave velocity (PWV) is the distance a pulse wave travels in a specific arterial segment divided by the time it takes to travel that distance (units: m/sec). PWV is a marker of cardiovascular risk.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '36223763', 'type': 'BACKGROUND', 'citation': 'Murashige D, Jung JW, Neinast MD, Levin MG, Chu Q, Lambert JP, Garbincius JF, Kim B, Hoshino A, Marti-Pamies I, McDaid KS, Shewale SV, Flam E, Yang S, Roberts E, Li L, Morley MP, Bedi KC Jr, Hyman MC, Frankel DS, Margulies KB, Assoian RK, Elrod JW, Jang C, Rabinowitz JD, Arany Z. Extra-cardiac BCAA catabolism lowers blood pressure and protects from heart failure. Cell Metab. 2022 Nov 1;34(11):1749-1764.e7. doi: 10.1016/j.cmet.2022.09.008. Epub 2022 Oct 11.'}, {'pmid': '35717342', 'type': 'BACKGROUND', 'citation': 'Vanweert F, Neinast M, Tapia EE, van de Weijer T, Hoeks J, Schrauwen-Hinderling VB, Blair MC, Bornstein MR, Hesselink MKC, Schrauwen P, Arany Z, Phielix E. A randomized placebo-controlled clinical trial for pharmacological activation of BCAA catabolism in patients with type 2 diabetes. Nat Commun. 2022 Jun 18;13(1):3508. doi: 10.1038/s41467-022-31249-9.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate if the drug sodium phenylbutyrate (NaPB) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age and less than 60.\n* Healthy subjects will have no history of diabetes or prediabetes.\n* Diabetes subjects can be either insulin dependent or not.\n* Able to provide written consent and to comply with the procedures of the study protocol.\n\nExclusion Criteria:\n\n* Age \\<18 or \\>60\n* Pregnant or lactating women.\n* Subjects with hypertension or taking any vasodilatory medications, any steroidal drugs, haloperidol, or valproic acid.\n* Patients with congestive heart failure, severe renal insufficiency, hepatic failure, or known sodium retention with oedema.\n* Active alcohol or substance abuse.\n* Use of tobacco within the previous six months.\n* Unble to provide written consent and to comply with the procedures of the study protocol.'}, 'identificationModule': {'nctId': 'NCT06645769', 'acronym': 'NAPVAT', 'briefTitle': 'Na-Phenylbutyrate VAscular Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Na-Phenylbutyrate VAscular Trial', 'orgStudyIdInfo': {'id': 'NAPVAT'}, 'secondaryIdInfos': [{'id': 'R01HL152446', 'link': 'https://reporter.nih.gov/quickSearch/R01HL152446', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NaPB administration', 'interventionNames': ['Drug: Sodium Phenylbutyrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo control', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Sodium Phenylbutyrate', 'type': 'DRUG', 'description': 'will be compared to placebo', 'armGroupLabels': ['NaPB administration']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'will be compared to NaPB', 'armGroupLabels': ['Placebo control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Claire Brady', 'role': 'CONTACT', 'email': 'Claire.Brady@Pennmedicine.upenn.edu', 'phone': '8573344274'}], 'overallOfficials': [{'name': 'Zoltan Arany, MDPHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}