Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
NCT06108076

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

Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-01-21

10

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center at San Antonio

Lead Sponsor

N

National Center for Advancing Translational Sciences (NCATS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must be on a stable dose of guideline-directed medications for Heart Failure (HF).
  • Patients must have an established diagnosis of heart failure documented by imaging within the last 6 months.
  • Age between 18 and 80 years.
  • Body Mass Index (BMI) between 23 and 38 kg/m2.
  • Glycated hemoglobin (HbA1c) between 6.0% and 10.0%.
  • Blood Pressure less than 145/85 mmHg.
  • Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min/1.73 m2.
  • Women of child-bearing age must be willing to use contraception if applicable.
Not Eligible

You will not qualify if you...

  • Patients treated with Sodium-Glucose Transport Protein (SGLT2i's) or medications that may impair heart function or worsen glycemic control.
  • Pregnancy, lactation, or plans to become pregnant; negative pregnancy test required before each MRI.
  • Allergy or sensitivity to study drugs or ingredients.
  • Current drug or alcohol use or dependence that would interfere with study adherence.
  • Inability or unwillingness to provide written informed consent.
  • History of cancer except basal or squamous cell cancer resolved/remission for 5 years.
  • Cardiovascular event within the last 3 months.
  • Major organ or metabolic diseases or physical limitations preventing study completion.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

Loading map...

Research Team

C

Carolina Solis-Herrera, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here