Effects of oral ketones on heart function in patients with diabetes and heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.