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

Recruiting now · Early Phase 1

Conditions studied: Type 2 Diabetes, Heart Failure, Reduced Ejection Fraction

In brief

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.

Key facts

Study ID

NCT06108076

Run by

The University of Texas Health Science Center at San Antonio

People needed

10

Starts

2024-01-16

Expected to finish

2026-12-31

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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