NCT06108076RecruitingEarly phase 1
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 18 Oct 2023
- Start date
- 16 Jan 2024
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Heart failure, Stroke, Type 2 diabetes
- NCT number
- NCT06108076
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 16 Jan 2024 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Other illness
- 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.
Lab values
- Patients treated with Sodium-Glucose Transport Protein (SGLT2i's) or medications that may impair heart function or acutely worsen glycemic control will be excluded.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.