SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Recruiting · NCT05057806 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Health Science Center at San Antonio
View the official record on ClinicalTrials.gov →Interventions studied
Empagliflozin 25 MGPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Texas Health Science Center at San Antonio - San Antonio, Texas, United States