[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443699":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":68,"collaborators":70,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":42,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":42,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin Group","EXPERIMENTAL","Subjects will be randomized 2:1 to receive empagliflozin, 25mg\u002Fday for 3 months",[13],"Drug: Empagliflozin 25 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Subjects will be randomized to receive the empagliflozin placebo for 3 months",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Empagliflozin 25 MG","Empagliflozin 25MG will be administered orally once per day for 3 months",[9],[27],"Jardiance",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","The placebo will be administered orally once per day for 3 months",[15],[33],"Placebo for Empagliflozin",[35],{"name":36,"affiliation":5,"role":37},"Carolina Solis-Herrera, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","210-567-4900",null,"solisherrera@uthscsa.edu",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Francisca M Acosta, PhD","210-450-8677","acostafm@uthscsa.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Texas Health Science Center at San Antonio","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-98.49363,29.42412,{"lat":61,"lon":60},[64,66,67],{"name":36,"role":40,"phone":65,"phoneExt":42,"email":43},"210-567-4800",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},{"name":36,"role":37,"phone":42,"phoneExt":42,"email":42},{"type":69,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[71,73],{"name":72,"class":6},"Doris Duke Charitable Foundation",{"name":74,"class":75},"Max and Minnie Tomerlin Voelcker Fund","UNKNOWN","100443699","early-phase-1-sglt2-inhibitors-ketones-and-cardiovascular-benefit-research-plan-100443699",false,"NCT05057806","SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan","Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan","Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \\\u003C50%\n* Age 18-80 years\n* BMI 23-38 kg\u002Fm2\n* Glycated hemoglobin (HbA1c) 5.5-10%\n* Blood Pressure (BP) ≤ 145\u002F85 mmHg\n* Estimated glomerular filtration rate (eGFR) ≥30 ml\u002Fmin•1.73 m2\n* Stable dose of guideline-directed medications for heart failure and Diabetes\n* Stable body weight (±4 pounds) over the last 3 months\n* Does not suffer from severe claustrophobia\n* No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)\n\nExclusion Criteria:\n\n* Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone\n* Pregnancy, lactation or plans to become pregnant\n* Allergy\u002Fsensitivity to study drugs or their ingredients\n* Cancer\n* Current drug or alcohol use or dependence\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent","ALL","18 Years","80 Years",{"count":87,"type":88},30,"ESTIMATED","INTERVENTIONAL",[91],"EARLY_PHASE1","The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.",[94,95],"Type2 Diabetes","Heart Failure With Preserved Ejection Fraction",[97,98],"Ketones","Cardiovascular benefit","2026-03-30",{"date":101,"type":102},"2026-04-06","ACTUAL",{"date":104,"type":102},"2021-01-13",{"date":106,"type":88},"2027-03-31",{"name":5,"class":6},1]