SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

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.

Eligibility

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 and Diabetes
* Stable body weight (±4 pounds) over the last 3 months
* Does not suffer from severe claustrophobia
* No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Exclusion Criteria:

* Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
* Pregnancy, lactation or plans to become pregnant
* Allergy/sensitivity to study drugs or their ingredients
* Cancer
* Current drug or alcohol use or dependence
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Conditions4

Interventions1

Locations1 site

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