SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Lay Description
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.
Category
- Heart, Vascular and Blood
- IRB Number
- 20210528HU
- NCT Number
- NCT05057806
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Stable body weight (±4 pounds) over the last 3 months
Exclusion Criteria
- Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
- Resting heart rate >120 bpm
- Systolic BP>180mmHg and/or diastolic BP >100mmHg
- Resting percentage of blood oxygen saturation (SpO2) < 85%
- Physical disability preventing safe performance of the exercise protocol.
Study Design
Arm Groups
Study Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu
Principal Investigator
Carolina Solis-Herrera