Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
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
Study Start (Actual) 2024-01-16
Primary Completion (Estimated) 2024-10-31
Study Completion (Estimated) 2025-01-31
Enrollment (Estimated) 10
Study Type INTERVENTIONAL
Phase EARLY_PHASE1
Locations:
📍 San Antonio, Texas, United States

Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2023-10-18
  • First Submitted that Met QC Criteria2023-10-26
  • First Posted2023-10-30

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-04-10
  • Last Update Posted2024-04-11
  • Last Verified2024-04