Back to search results

Oral Ketones for Heart Failure and Type 2 Diabetes

This study is looking at how a nutritional supplement called Ketone Monoester (KE) affects people with Type 2 Diabetes and a type of heart failure called Heart Failure with Reduced Ejection Fraction (HFrEF). Researchers want to see if Ketone Monoester (KE) can improve how well the heart works. You might be able to join if you are 18-80 years old, have stable heart failure medications, and your BMI (Body Mass Index) is between 23-38 kg/m2. The study will measure heart function after a single dose and after several days of taking Ketone Monoester (KE). The study is currently unclear about its recruitment status and plans to enroll 10 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.
What's involved
You will have a screening visit, then two separate doses of oral Ketone Monoester (KE) during a second visit, followed by cardiac MRIs and multiple blood draws. You will return for a third MRI and more blood draws approximately 24 hours later.
Compensation
Not stated in the trial record.
Follow-up
Your heart function will be measured up to 24 hours after an acute dose and up to 7 days after chronic dosing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06108076

Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes

Recruiting
EARLY_PHASE1Ages 18–80InterventionalTreatment
The University of Texas Health Science Center at San Antonio
~10 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:Ketone Monoester (KE)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cardiac Efficiency after acute dose (Left-ventricular function)
Measured over 1.5 hours to 24 hours
+1 more outcome measured

Conditions

Type 2 Diabetes
Heart Failure, Reduced Ejection Fraction

Explore related trials

Heart FailureType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Carolina Solis-Herrera, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Carolina Solis-Herrera, MD
[email protected]
210-567-4900
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Cardiac Efficiency after acute dose (Left-ventricular function)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)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.