Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes

NCT06108076 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 20230420HU1UM1TR004538-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1.5 hours to 7 days

Secondary Outcomes (8)

• Six minute walk test

  Baseline to 7 days

• Acetoacetate

  Baseline to 7 days

• Glucose

  Baseline to 7 days

• Free Fatty Acids (FFAs)

  Baseline to 7 days

• Insulin/C-peptide

  Baseline to 7 days

Study Arms (1)

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

Drug: Ketone Monoester (KE)

Interventions

Ketone Monoester (KE) DRUG

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

Also known as: DeltaG

Ketone Ester administration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Heart Failure, Systolic

Interventions

rVSV-deltaG-spike COVID-19 vaccine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Carolina Solis-Herrera, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Solis-Herrera, MD

CONTACT

210-567-4900; solisherrera@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, pilot trial

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 30, 2023
• Study Start: January 16, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At one year after study primary completion on ClinicalTrials.gov and at study completion at the time of publication in a peer review journal

Locations

US (1)