[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533735":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":42,"locations":51,"responsibleParty":75,"collaborators":77,"id":81,"slug":33,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":33,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":33,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":54,"whyStopped":33,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,15],{"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",[13,14],"Drug: Empagliflozin 25 MG Oral Tablet","Drug: Acipimox 250 Mg Oral Capsule",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo group","PLACEBO_COMPARATOR","Subjects will be randomized to receive the empagliflozin placebo for 3 months",[20,14],"Drug: Placebo",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Empagliflozin 25 MG Oral Tablet","Empagliflozin 25MG will be administered orally once per day for 3 months",[9],[28],"jardiance",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","The placebo will be administered orally once per day for 3 months",[16],null,{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Acipimox 250 Mg Oral Capsule","subjects will be started on acipimox 250mg every 6 hours for 8 days while on continued empagliflozin\u002Fplacebo therapy. This will be added at the end of 3 months after they finished baseline studies",[9,16],[39],{"name":40,"affiliation":5,"role":41},"Ralph DeFronzo, MD","PRINCIPAL_INVESTIGATOR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":33,"email":46},"CONTACT","210-567-6691","defronzo@uthscsa.edu",{"name":48,"role":44,"phone":49,"phoneExt":33,"email":50},"Sivaram Neppala, MD","210-358-7200","neppalas@uthscsa.edu",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Texas Diabetes Institute - University Health System","RECRUITING","San Antonio","Texas","78207","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-98.49363,29.42412,{"lat":64,"lon":63},[67,68,71,72,74],{"name":48,"role":44,"phone":49,"phoneExt":33,"email":50},{"name":69,"role":44,"phone":49,"phoneExt":33,"email":70},"Jemema Rajan, MD","rajanj@uthscsa.edu",{"name":40,"role":41,"phone":33,"phoneExt":33,"email":33},{"name":48,"role":73,"phone":33,"phoneExt":33,"email":33},"SUB_INVESTIGATOR",{"name":69,"role":73,"phone":33,"phoneExt":33,"email":33},{"type":76,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[78],{"name":79,"class":80},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100533735",false,"NCT06229678","Ketones, SGLT2, HFrEF","Ketones, Muscle Metabolism, and SGLT2 Inhibitors","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 23-44 kg\u002Fm2\n* Glycated hemoglobin (HbA1c) 6.0-10.0%\n* Blood Pressure (BP) ≤ 145\u002F85 mmHg\n* Estimated glomerular filtration rate (eGFR) ≥30 ml\u002Fmin•1.73 m2\n* Only Type 2 diabetics treated with diet\u002Fexercise, metformin, sulfonylureas, metformin\u002Fsulfonylurea, Glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin\n* Stable body weight (±4 pounds) over the previous 3 months prior to enrollment\n* Ability to understand study procedures and to comply with them for the entire length of the study.\n\nExclusion Criteria:\n\n* Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, hypertrophic obstructive cardiomyopathy.\n* Significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose or addition of another heart failure medication)\n* Type 2 Diabetics treated with Dipeptidyl Peptidase-4 Inhibitor (DPP4i) or pioglitazone\n* Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each MRI study to assess current status. For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.\n* Allergy\u002Fsensitivity to study drugs or their ingredients.\n* Cancer.\n* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent.","ALL","18 Years","70 Years",{"count":91,"type":92},71,"ESTIMATED","INTERVENTIONAL",[95],"EARLY_PHASE1","The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function",[98,99],"Type2diabetes","Heart Failure With Reduced Ejection Fraction",[101,102],"ketones","cardiovascular benefit","2026-02-03",{"date":105,"type":106},"2026-02-05","ACTUAL",{"date":108,"type":106},"2024-01-25",{"date":110,"type":92},"2027-03-01",{"name":5,"class":6},1]