Overview

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborator:
Doris Duke Charitable Foundation
Treatments:
Empagliflozin
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

- 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.