[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555346":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":10,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketogenic Diet with sotagliflozin",null,"40 volunteers will take a SGLT1\u002F2i, sotagliflozin (400 mg QD), for 7 days prior to the PET scan visit and will undergo FDG PET\u002FCT after 1-3 day of dietary modification (ketogenic diet for at least 3-9 meals) and overnight fasting prior to FDG injection.",[13],"Drug: Sotagliflozin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sotagliflozin","Sodium-glucose cotransporter-1\u002F2 inhibitor",[9],[21],"INPEFA",[23],{"name":24,"affiliation":5,"role":25},"Paco Bravo, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Mary E Hansbury, BS","CONTACT","2157468192","mary.hansbury@pennmedicine.upenn.edu",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Erin Schubert, BA","215-573-6569","erin.schubert@pennmedicine.upenn.edu",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-75.16362,39.95238,{"lat":48,"lon":47},[51,53,55],{"name":52,"role":29,"phone":30,"phoneExt":10,"email":31},"Mary E Hansbury",{"name":54,"role":29,"phone":10,"phoneExt":10,"email":35},"Erin Schubert",{"name":24,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":25,"investigatorFullName":24,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Assistant Professor of Radiology and Medicine; Divisions of Nuclear Medicine, Cardiothoracic Imaging and Cardiovascular Medicine; Director, Nuclear Cardiology and Cardiovascular Molecular Imaging",[59],{"name":60,"class":6},"Duke University","100555346","diagnostic-utility-of-sglt12-inhibition-to-facilitate-myocardial-glucose-suppression-100555346",false,"NCT06510894","Diagnostic Utility of SGLT1\u002F2 Inhibition to Facilitate Myocardial Glucose Suppression","Diagnostic Utility of SGLT1\u002F2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET","Inclusion Criteria:\n\n1. Adult patients, at least 18 years of age\n2. No history of cardiovascular disease, including hypertension, hyperlipidemia, diabetes mellitus, heart failure, coronary artery disease, cardiac surgery, arrhythmias per medical record review and\u002For self-report\n3. No history of chronic liver or kidney disease per medical record review and\u002For self-report.\n4. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n1. Females who are pregnant or breast-feeding will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test during the screening visit and prior to FDG injection.\n2. Participants who are currently taking diuretics for any indication.\n3. Participants with an eGFR level \\\u003C30 mL\u002Fmin\u002F1.73m2.\n4. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.\n5. Any other medical or psychological condition that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.",true,"ALL",{"count":71,"type":72},40,"ESTIMATED","OBSERVATIONAL","This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1\u002F2 inhibition (SGLT1\u002F2) on myocardial glucose suppression on FDG PET\u002FCT. The investigators will test whether the addition of a SGLT1\u002F2 inhibitor (SGLT1\u002F2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET.\n\nParticipants will be asked to:\n\n* undergo a screening visit that includes blood tests, vitals, and questions regarding health history\u002Fmedications\n* take the provided sotagliflozin as instructed for 7 days leading up to the scan\n* follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan\n* undergo an FDG PET\u002FCT scan, which includes vitals and blood draws",[76],"Cardiac Sarcoidosis",[78,79,80,81,82,83,84,85],"sarcoidosis","Cardiac Sacroidosis","SGLT1\u002F2 Inhibition","Myocardial Glucose Suppression","Ketogenic Diet","sotagliflozin","Healthy volunteer","PET\u002FCT","2026-01-06",{"date":88,"type":89},"2026-01-07","ACTUAL",{"date":91,"type":89},"2024-11-20",{"date":93,"type":72},"2027-12-31",{"name":5,"class":6},1]