RECRUITING

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

Conditions

Type 2 Diabetes Heart Failure, Reduced Ejection Fraction Ketone esters Cardiopulmonary benefits Left Ventricular function Stroke volume Cardiac output

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-16

Study Completion:2025-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06108076

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Carolina Solis-Herrera, MD

CONTACT

210-567-4900

solisherrera@uthscsa.edu

Principal Investigator

Carolina Solis-Herrera, MD

PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Study Locations (Sites)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: 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

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

Study Start Date2024-01-16

Study Completion Date2025-01-31

Study Record Updates

Study Start Date2024-01-16

Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

Ketone esters
Cardiopulmonary benefits
Left Ventricular function
Stroke volume
Cardiac output

Additional Relevant MeSH Terms

Type 2 Diabetes
Heart Failure, Reduced Ejection Fraction