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Recruiting EARLY_Phase 1 NCT06229678

Ketones, SGLT2, HFrEF

Trial Parameters

Condition Type2diabetes
Sponsor The University of Texas Health Science Center at San Antonio
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 71
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-01-25
Completion 2026-11-01
Interventions
Empagliflozin 25 MG Oral TabletPlaceboAcipimox 250 Mg Oral Capsule

Brief Summary

The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function

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 23-44 kg/m2 * Glycated hemoglobin (HbA1c) 6.0-10.0% * Blood Pressure (BP) ≤ 145/85 mmHg * Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2 * Only Type 2 diabetics treated with diet/exercise, metformin, sulfonylureas, metformin/sulfonylurea, Glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin * Stable body weight (±4 pounds) over the previous 3 months prior to enrollment * Ability to understand study procedures and to comply with them for the entire length of the study. Exclusion Criteria: * Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, hypertrophic obstructive cardiomyopathy. * Significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose or addition of an

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