SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
RecruitingEarly phase 1
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Type 2 Diabetes Mellitus * Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50% * Age 18-80 years * BMI 23-38 kg/m2 * Glycated hemoglobin (HbA1c) 5.5-10% * Blood Pressure (BP) ≤ 145/85 mmHg * Estimated glomerular filtration rate (eGFR) ≥30 ml/min•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) Exclusion Criteria: * 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/sensitivity to study drugs or their ingredients * Cancer * Current drug or alcohol use or dependence * Inability or unwillingness of individual or legal guardian/representative to give written informed consent
About the study
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.
What is being tested
- Empagliflozin 25 MG (drug)
- Placebo (drug)
Sponsor: The University of Texas Health Science Center at San Antonio · Participants: 30 · Started: Jan 13, 2021
Contact the study team
- Carolina Solis-Herrera, MD · Phone: 210-567-4900
- Francisca M Acosta, PhD · Phone: 210-450-8677
Official record on ClinicalTrials.gov — NCT05057806
Locations in the U.S.
| Texas | University of Texas Health Science Center at San Antonio, San Antonio |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.