Recruiting
Early Phase 1

Ketones

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06108076

Conditions

Type 2 Diabetes

Heart Failure, Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketone Monoester (KE)

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Heart Failure, Reduced Ejection Fraction

Study ID

NCT06108076

Start date

Jan 16, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketone Ester administration

1. Monitored administration of oral Ketone monoester at 400mg/kg dosed twice on visit 2 (cardiac MRI day)
2. Self administered oral β-hydroxybutyrate (BOHB) at 400mg/kg/day for a period of 6 days

Interventions

Ketone Monoester (KE)

Ketones are a nutritional supplement currently used by athletes for their performance enhancing effects - specifically their cardio-pulmonary benefits

Primary outcome measure

  • Cardiac Efficiency after acute dose (Left-ventricular function) [ Time Frame: 1.5 hours to 24 hours ]
  • Cardiac Efficiency after chronic dosing (Left-ventricular function) [ Time Frame: 1.5 hours to 7 days ]

Central Contacts and Locations

Central contacts

Carolina Solis-Herrera, MD

210-567-4900solisherrera@uthscsa.edu

Locations

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Carolina Solis-Herrera, MD

210-567-4900solisherrera@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • Ketone esters
  • Cardiopulmonary benefits
  • Left Ventricular function
  • Stroke volume
  • Cardiac output

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-01-21.