[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565714":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":11,"responsibleParty":39,"collaborators":41,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":11},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NaPB administration","EXPERIMENTAL",null,[13],"Drug: Sodium Phenylbutyrate",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo control","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Sodium Phenylbutyrate","will be compared to placebo",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","will be compared to NaPB",[15],[30],{"name":31,"affiliation":5,"role":32},"Zoltan Arany, MDPHD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Claire Brady","CONTACT","8573344274","Claire.Brady@Pennmedicine.upenn.edu",{"type":40,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[42],{"name":43,"class":44},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100565714","early-phase-1-na-phenylbutyrate-vascular-trial-100565714",false,"NCT06645769","Na-Phenylbutyrate VAscular Trial","NAPVAT","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 \\\u003C18 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.",true,"ALL","18 Years","60 Years",{"count":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61],"EARLY_PHASE1","This study will investigate if the drug sodium phenylbutyrate (NaPB) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.",[64],"Diabetes","NOT_YET_RECRUITING","2026-07-27",{"date":68,"type":69},"2026-07-28","ACTUAL",{"date":71,"type":58},"2027-06-01",{"date":73,"type":58},"2029-06-01",{"name":5,"class":6}]