NCT06108076 · The University of Texas Health Science Center at San Antonio
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
What this study is about
This study will provide insight into whether cardiac function changes with taken by mouth 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.
View original scientific description
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.
Interventions
DRUG
Ketone Monoester (KE)
Ketones are a nutritional supplement currently used by athletes for their performance enhancing effects - specifically their cardio-pulmonary benefits
Primary outcome measures
Cardiac Efficiency after acute dose (Left-ventricular function)
Time frame: 1.5 hours to 24 hours
Change in cardiac efficiency after acute dosing of KE, measured by change in Left-ventricular function measured using Cardiac MRI and expressed as a percentage.
Cardiac Efficiency after chronic dosing (Left-ventricular function)
Time frame: 1.5 hours to 7 days
Change in cardiac efficiency after chronic (7 day) dosing of KE, measured by change in Left-Ventricular function measured using Cardiac MRI and expressed as a percentage.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Antonio, Texas
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations