[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05057806":3,"trial-entities:NCT05057806":137,"trial-summary:NCT05057806":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":64,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":15,"eligibility_criteria":83,"std_ages":104,"locations":107,"central_contacts":129,"overall_officials":133,"references":135,"see_also_links":136},"NCT05057806","HSC20210528H","SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan","Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan","RECRUITING","2027-03-31","2026-03","2026-04-06","2021-01-13","The University of Texas Health Science Center at San Antonio","OTHER",false,"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.","The study team will examine effects of elevated plasma ketones caused by 12-week treatment with an SGLT2i (empagliflozin) treatment in participants with T2DM and HF. The study team will focus on three possible mechanisms of action for these effects and test the following:\n\n(i) Skeletal muscle bioenergetics. Using 31P-MRS, the team will quantitate phosphocreatine \\[PCr\\], ATP, inorganic phosphate, phosphodiester, and intracellular pH. With 1H-MRS, and will measure intramyocellular lipid content at rest and ATPmax production after exercise. The team will examine the relationships between phosphorous metabolite concentrations, intramyocellular lipid content, and ATP generation before and after 12 weeks of SGLT2 inhibition.\n\n(ii) Cardiopulmonary functional capacity.\n\n(iii) Improvements in Patient-Reported Outcomes (PRO). The Patient-Reported Outcomes Measure Information System (PROMIS) Item Bank v2.0 - Physical Function - Short Form 20a will be used to evaluate self-reported physical function and well-being. This tool is a well-developed and validated method to obtain patient self-reported parameters of health in adults.",[19,20],"Type2 Diabetes","Heart Failure With Preserved Ejection Fraction",[22,23],"Ketones","Cardiovascular benefit","INTERVENTIONAL","BASIC_SCIENCE",[27],"EARLY_PHASE1",{"count":29,"type":30},30,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Empagliflozin 25 MG","Empagliflozin 25MG will be administered orally once per day for 3 months",[37],"Empagliflozin Group",[39],"Jardiance",{"type":33,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Placebo","The placebo will be administered orally once per day for 3 months",[44],"Placebo group",[46],"Placebo for Empagliflozin",[48,52,55,58,61],{"measure":49,"description":50,"timeFrame":51},"Change in Phosphocreatine","A measure of phosphocreatine change from baseline to study end","Baseline to 3 months",{"measure":53,"description":54,"timeFrame":51},"Change in Adenosine Triphosphate (ATP)","A measure of ATP change from baseline to study end",{"measure":56,"description":57,"timeFrame":51},"Change in Inorganic Phosphate","A measure of inorganic phosphate change from baseline to study end",{"measure":59,"description":60,"timeFrame":51},"Change in Phosphodiester","A measure of phosphodiester change from baseline to study end",{"measure":62,"description":63,"timeFrame":51},"ATPmax production","Exercise induced ATPmax production change",[65,68,71,74,77],{"measure":66,"description":67,"timeFrame":51},"Plasma Beta-hydroxybutyrate (β-OH-B)","Change in β-OH-B",{"measure":69,"description":70,"timeFrame":51},"Acetoacetate concentrations","Change in acetoacetate concentrations",{"measure":72,"description":73,"timeFrame":51},"Cardiopulmonary Function","Change in cardiopulmonary functional capacity using oxygen uptake (VO2)",{"measure":75,"description":76,"timeFrame":51},"6 minute walk test","Change in the distance that can be covered in a 6 minute walk test",{"measure":78,"description":79,"timeFrame":51},"Patient-Reported Outcomes Measure Information System (PROMIS)","Change in Physical function will be assessed by the PROMIS Item band v2.0 -Physical Function -Short Form 20a to evaluate patient-reported outcomes of physical function and well being.","ALL","18 Years","80 Years",{"inclusion":84,"exclusion":96,"raw_text":103},[85,86,87,88,89,90,91,92,93,94,95],"Type 2 Diabetes Mellitus","Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \\\u003C50%","Age 18-80 years","BMI 23-38 kg\u002Fm2","Glycated hemoglobin (HbA1c) 5.5-10%","Blood Pressure (BP) ≤ 145\u002F85 mmHg","Estimated glomerular filtration rate (eGFR) ≥30 ml\u002Fmin•1.73 m2","Stable dose of guideline-directed medications for heart failure and Diabetes","Stable body weight (±4 pounds) over the last 3 months","Does not suffer from severe claustrophobia","No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)",[97,98,99,100,101,102],"Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone","Pregnancy, lactation or plans to become pregnant","Allergy\u002Fsensitivity to study drugs or their ingredients","Cancer","Current drug or alcohol use or dependence","Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent","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",[105,106],"ADULT","OLDER_ADULT",[108],{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":126},"University of Texas Health Science Center at San Antonio","San Antonio","Texas","78229","United States",[115,120,124],{"name":116,"role":117,"phone":118,"email":119},"Carolina Solis-Herrera, MD","CONTACT","210-567-4800","solisherrera@uthscsa.edu",{"name":121,"role":117,"phone":122,"email":123},"Francisca M Acosta, PhD","210-450-8677","acostafm@uthscsa.edu",{"name":116,"role":125},"PRINCIPAL_INVESTIGATOR",{"lat":127,"lon":128},29.42412,-98.49363,[130,132],{"name":116,"role":117,"phone":131,"email":119},"210-567-4900",{"name":121,"role":117,"phone":122,"email":123},[134],{"name":116,"affiliation":13,"role":125},[],[],{"nct_id":4,"conditions":138,"biomarkers":140},[139,85],"Heart Failure",[],{"nct_id":4,"found":142,"summary":143,"prompt_version":153},true,{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This interventional study plans to enroll 30 participants. It compares empagliflozin to a placebo (an inactive pill).","completed","Empagliflozin for Type 2 Diabetes and Heart Failure","This study is looking at how empagliflozin, a medication, affects people with Type 2 Diabetes and a type of heart failure called Heart Failure with Preserved Ejection Fraction. Researchers want to understand how empagliflozin, and the ketones it can produce, impact your muscles and heart. They will measure changes in important energy chemicals in your body, like Phosphocreatine and Adenosine Triphosphate (ATP), over 3 months. You might be able to join if you are 18-80 years old, have Type 2 Diabetes, and certain heart failure criteria. The study aims to enroll 30 participants and is currently unclear on its recruitment status.","The primary measurements for this study are taken from the beginning (Baseline) to 3 months.",101,"Participants will take either empagliflozin or a placebo orally once per day for 3 months. Specific visits or procedures are not detailed.","Not stated in the trial record.",[],"v2"]