Testing Oral Ketone Esters in People With Heart Failure and Diabetes
Tests a ketone drink on heart function in adults with diabetes and heart failure.
Plain-language title generated from the registry record
Registry title: Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
Key facts
- Where
- San Antonio, United StatesSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06108076, who can take part
Where in United States
- University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Texas Health Science Center at San Antonio
- Trial code
- NCT06108076
- Record updated
- 21 January 2026
- Original 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.Read full original descriptionShow less
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
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.
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: Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements; Allergy/sensitivity to study drugs or their ingredients; Subjects with a history of cancer (except basal or squamous cell cancer that has been resolved/remission for 5 years); Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study; 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; Inability or unwillingness of individual or legal guardian/representative to give written informed consent; Cardiovascular event within the last 3 months.