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.