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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Type 2 Diabetes
Intervention / Treatment

-

Contacts and Locations

San Antonio

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Carolina Solis-Herrera, MD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center San Antonio

Study Record Dates

2025-01-31