Effects of oral ketones on heart function in patients with diabetes and heart failure
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
This study tests if taking ketone supplements can help improve heart function in people with diabetes and heart failure.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06108076 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of oral Ketone Esters (KE) on cardiac function in patients diagnosed with Type 2 Diabetes Mellitus and Heart Failure with reduced ejection fraction. Participants will receive two doses of KE during a visit, followed by multiple cardiac MRI scans to assess changes in heart function. Blood samples will be collected at various intervals to analyze metabolic responses to the ketones. The study aims to determine if KE can improve heart performance in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with stable heart failure on guideline-directed medications and controlled diabetes.
Not a fit: Patients with certain contraindications, such as those on specific heart medications or with severe renal impairment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary interventions that improve heart function in patients with diabetes and heart failure.
How similar studies have performed: While the use of ketone esters in cardiac health is a relatively novel approach, preliminary studies suggest potential benefits, though comprehensive data is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Sodium-Glucose Transport Protein (SGLT2i's) or medications that may impair heart function or acutely worsen glycemic control will be excluded. * Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each Magnetic resonance imaging (MRI) study to assess current status. * Allergy/sensitivity to study drugs or their ingredients. * Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent. * Subjects with a history of cancer (except basal or squamous cell cancer that has been resolved/remission for 5 years) * Cardiovascular event within the last 3 months * Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study.
Where this trial is running
San Antonio, Texas
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Carolina Solis-Herrera, MD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Carolina Solis-Herrera, MD
- Email: solisherrera@uthscsa.edu
- Phone: 210-567-4900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.