Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
The University of Texas Health Science Center at San Antonio
Summary
This study will provide insight into whether cardiac function changes with oral Ketone Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by cardiac muscle and their uptake is not dependent upon insulin or influenced by insulin resistance.
Description
After the screening visit, subject will take two separate doses of oral ketones during visit two. Subjects will have their first dose (400mg/kg) upon completion of the baseline Magnetic Resonance Imaging (MRI), and then a second dose (400mg/kg) approximately 1.5 hours after their consumption of the 1st dose. Approximately 1.5 hours after their second dose (3hr since first dose), the subject will undergo a second cardiac MRI. Baseline Blood samples of Beta-hydroxybutyrate (BOHB), acetoacetate (ACAC), Free Fatty Acids (FFA), insulin, c-peptide, glucagon, and an additional 10ml (for storage and l…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects must be on a stable dose of guideline-directed medications for Heart Failure (HF). * Patients will have an established diagnosis of HF before the screening visit, documented by an acceptable imaging modality in the last 6 months. * Age = 18-80 y * Body Mass Index (BMI) =23-38 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 * For women of child-bearing age (WOCBA) willingness to use contraception, if applicable. Exclusion Criteria: * Patients treated with Sod…
Interventions
- DrugKetone Monoester (KE)
Ketones are a nutritional supplement currently used by athletes for their performance enhancing effects - specifically their cardio-pulmonary benefits
Location
- University of Texas Health Science Center at San AntonioSan Antonio, Texas