Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
NCT06108076 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-01-21
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
Interventions
- DRUG
-
Ketone Monoester (KE)
Ketones are a nutritional supplement currently used by athletes for their performance enhancing effects - specifically their cardio-pulmonary benefits
Sponsors & Collaborators
-
National Center for Advancing Translational Sciences (NCATS)
collaborator NIH -
The University of Texas Health Science Center at San Antonio
lead OTHER
Principal Investigators
-
Carolina Solis-Herrera, MD · University of Texas Health Science Center San Antonio
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-16
- Primary Completion
- 2026-07-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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