Type 2 DiabetesEarly Phase 1NCT06108076
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
A Early Phase 1 study testing Ketone Monoester (KE) in people with Type 2 Diabetes and Heart Failure, Reduced Ejection Fraction, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Heart Failure, Reduced Ejection Fraction
- What is being tested?
- Ketone Monoester (KE)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Carolina Solis-Herrera, MD, 210-567-4900, solisherrera@uthscsa.edu
About this study
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.
Read the detailed description
After the screening visit, subject will take two separate doses of oral ketones during visit two. Subjects will have their first dose (400mg/kg) upon completion of the baseline Magnetic Resonance Imaging (MRI), and then a second dose (400mg/kg) approximately 1.5 hours after their consumption of the 1st dose. Approximately 1.5 hours after their second dose (3hr since first dose), the subject will undergo a second cardiac MRI. Baseline Blood samples of Beta-hydroxybutyrate (BOHB), acetoacetate (ACAC), Free Fatty Acids (FFA), insulin, c-peptide, glucagon, and an additional 10ml (for storage and later analysis) will be drawn prior to their first dose, then every 30 minutes after their first dose, until completion of the second MRI, then a final blood draw upon completion of the MRI for a total of 8 blood draws during visit 2. An IV catheter will be placed into one antecubital vein by a study nurse for all blood draws during visit 2.
The subject will then be asked to return to complete a third MRI approximately 24 hours after their second MRI. Blood samples for BOHB, acetoacetate (ACAC), insulin, c-peptide and glucagon, and an additional 10 ml will be drawn prior to their third MRI. An IV catheter will be placed into one antecubital vein by a study nurse for all blood draws during visit 3.
After completion of the third MRI, subjects will be dosed KE 400mg/kg once daily until the visit 4 MRI can be completed.
Blood samples for BOHB, acetoacetate (ACAC), insulin, c-peptide, glucagon, proBNP, and an additional 10 ml will be drawn prior to their fourth MRI. An IV catheter will be placed into one antecubital vein by a study nurse for all blood draws during visit 4. The 4th MRI, based on subject and scanner availability at approximately Day 7
- Being tested
- Ketone Monoester (KE)
- Keywords
- Ketone esters, Cardiopulmonary benefits, Left Ventricular function, Stroke volume, Cardiac output
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Monoester (KE)Drug
Also called DeltaG
Ketones are a nutritional supplement currently used by athletes for their performance enhancing effects - specifically their cardio-pulmonary benefits
| Study group | Role | What they receive |
|---|---|---|
| Ketone Ester administration | Experimental | 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 Receives: Drug: Ketone Monoester (KE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Efficiency after acute dose (Left-ventricular function)
Change in cardiac efficiency after acute dosing of KE, measured by change in Left-ventricular function measured using Cardiac MRI and expressed as a percentage.
Measured: 1.5 hours to 24 hours
Cardiac Efficiency after chronic dosing (Left-ventricular function)
Change in cardiac efficiency after chronic (7 day) dosing of KE, measured by change in Left-Ventricular function measured using Cardiac MRI and expressed as a percentage.
Measured: 1.5 hours to 7 days
Secondary outcomes (8)
Six minute walk test
Participants will be asked to walk as far as possible for 6 minutes, escorted by a member of the research team.
Baseline to 7 day distance will be compared.
Measured: Baseline to 7 days
Acetoacetate
Baseline to 7 day level will be compared.
Measured: Baseline to 7 days
Glucose
Baseline to 7 day level will be compared.
Measured: Baseline to 7 days
Free Fatty Acids (FFAs)
Baseline to 7 day level will be compared.
Measured: Baseline to 7 days
Insulin/C-peptide
Baseline to 7 day level will be compared.
Measured: Baseline to 7 days
Glucagon
Baseline to 7 day level will be compared.
Measured: Baseline to 7 days
Beta-hydroxybutyrate
Baseline to 7 day level will be compared.
Measured: Baseline to 7 days
Patient Reported Outcomes Measure Information System (PROMIS) - Physical Function
This tool is a well-developed and validated method to obtain self-reported parameters of health in adults, we will be using: PROMIS® Item Bank v2.0 - Physical Function - Short Form 20a
Subjects will rank 20 questions from a scale of 1 - 5, with 5 being the highest physical function and 1 being the lowest. The score will be added up, and the Raw score will be converted to T-Score using the PROMIS Adult v2.0 Physical Function 20a Short Form Conversion Table.
Baseline to 7 day T-Score will be compared, with a Higher T-Score indicating higher physical function.
Measured: Baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start16 Jan 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, pilot trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Carolina Solis-Herrera, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108076
- Sponsor's protocol ID
- 20230420HU
- Other IDs
- 1UM1TR004538-01
- Status last verified
- Jan 2026
- First submitted
- 18 Oct 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected Individual Participant Data (IPD) that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
- ClinicalTrials.gov ID
- NCT06108076
- Acronym / sponsor ID
- 20230420HU
- Keywords
- Ketone esters, Cardiopulmonary benefits, Left Ventricular function, Stroke volume, Cardiac output
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After the screening visit, subject will take two separate doses of oral ketones during visit two. Subjects will have their first dose (400mg/kg) upon completion of the baseline Magnetic Resonance Imaging (MRI), and then a second dose (400mg/kg) approximately 1.5 hours after their consumption of the 1st dose. Approximately 1.5 hours after their second dose (3hr since first dose), the subject will undergo a second cardiac MRI. Baseline Blood samples of Beta-hydroxybutyrate (BOHB), acetoacetate (ACAC), Free Fatty Acids (FFA), insulin, c-peptide, glucagon, and an additional 10ml (for storage and later analysis) will be drawn prior to their first dose, then every 30 minutes after their first dose, until completion of the second MRI, then a final blood draw upon completion of the MRI for a total of 8 blood draws during visit 2. An IV catheter will be placed into one antecubital vein by a study nurse for all blood draws during visit 2.
The subject will then be asked to return to complete a third MRI approximately 24 hours after their second MRI. Blood samples for BOHB, acetoacetate (ACAC), insulin, c-peptide and glucagon, and an additional 10 ml will be drawn prior to their third MRI. An IV catheter will be placed into one antecubital vein by a study nurse for all blood draws during visit 3.
After completion of the third MRI, subjects will be dosed KE 400mg/kg once daily until the visit 4 MRI can be completed.
Blood samples for BOHB, acetoacetate (ACAC), insulin, c-peptide, glucagon, proBNP, and an additional 10 ml will be drawn prior to their fourth MRI. An IV catheter will be placed into one antecubital vein by a study nurse for all blood draws during visit 4. The 4th MRI, based on subject and scanner availability at approximately Day 7
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, pilot trial
| Arm | Type | Receives |
|---|---|---|
| Ketone Ester administration | Experimental | Drug: Ketone Monoester (KE)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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone Monoester (KE)Also: DeltaGKetones are a nutritional supplement currently used by athletes for their performance enhancing effects - specifically their cardio-pulmonary benefits | Drug | Ketone Ester administration |
Primary outcome
Cardiac Efficiency after acute dose (Left-ventricular function)
Time frame: 1.5 hours to 24 hours
Change in cardiac efficiency after acute dosing of KE, measured by change in Left-ventricular function measured using Cardiac MRI and expressed as a percentage.
Cardiac Efficiency after chronic dosing (Left-ventricular function)
Time frame: 1.5 hours to 7 days
Change in cardiac efficiency after chronic (7 day) dosing of KE, measured by change in Left-Ventricular function measured using Cardiac MRI and expressed as a percentage.
8 secondary outcomes
Six minute walk test
Time frame: Baseline to 7 days
Acetoacetate
Time frame: Baseline to 7 days
Glucose
Time frame: Baseline to 7 days
Free Fatty Acids (FFAs)
Time frame: Baseline to 7 days
Insulin/C-peptide
Time frame: Baseline to 7 days
Glucagon
Time frame: Baseline to 7 days
Beta-hydroxybutyrate
Time frame: Baseline to 7 days
Patient Reported Outcomes Measure Information System (PROMIS) - Physical Function
Time frame: Baseline to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. All collected Individual Participant Data (IPD) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolina Solis-Herrera, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketone Monoester (KE) in people with Type 2 Diabetes and Heart Failure, Reduced Ejection Fraction, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Solis-Herrera, MD (210-567-4900, solisherrera@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Efficiency after acute dose (Left-ventricular function) (time frame: 1.5 hours to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.