NCT06108076 Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
| NCT ID | NCT06108076 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-01-16 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-01-16 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Carolina Solis-Herrera, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT06108076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06108076 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06108076 currently recruiting?
Yes, NCT06108076 is actively recruiting participants. Contact the research team at solisherrera@uthscsa.edu for enrollment information.
Where is the NCT06108076 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT06108076 clinical trial?
NCT06108076 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Carolina Solis-Herrera, MD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 10 participants.
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