RecruitingEarly Phase 1NCT06229678

Ketones, SGLT2, HFrEF

Ketones, Muscle Metabolism, and SGLT2 Inhibitors

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

71 participants

Start Date

Jan 25, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Reduced Ejection Fraction Type2diabetes

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a class of diabetes medications called SGLT2 inhibitors affect energy use in the heart (specifically how the heart uses ketones as fuel) in patients who have both type 2 diabetes and heart failure with reduced pumping function. **You may be eligible if...** - You have type 2 diabetes - You have heart failure with reduced ejection fraction (less than 50%) classified as NYHA Class II or III - You are between 18 and 80 years old with a BMI between 23 and 44 - Your blood sugar (HbA1c) is between 6.0% and 10.0% - Your blood pressure is well-controlled (≤145/85 mmHg) - Your kidney function is adequate (eGFR ≥30) - Your weight has been stable for the past 3 months **You may NOT be eligible if...** - Your heart failure has a specific cause like severe valve disease, restrictive cardiomyopathy, or active myocarditis - You have type 1 diabetes - You are pregnant or breastfeeding - You have severe kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 25 MG Oral Tablet

Empagliflozin 25MG will be administered orally once per day for 3 months

DRUGPlacebo

The placebo will be administered orally once per day for 3 months

DRUGAcipimox 250 Mg Oral Capsule

subjects will be started on acipimox 250mg every 6 hours for 8 days while on continued empagliflozin/placebo therapy. This will be added at the end of 3 months after they finished baseline studies