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Ketones, SGLT2, HFrEF Study

This study is looking at how a medication called empagliflozin (an SGLT2 inhibitor) affects people with Type 2 Diabetes and a type of heart failure called Heart Failure with Reduced Ejection Fraction (HFrEF). Researchers want to see if empagliflozin, which can increase ketone levels in your body, improves how your heart and muscles work. You would receive either empagliflozin or a placebo (an inactive substance) for three months. At the end of this period, some participants will also receive acipimox for 8 days, which helps researchers understand the role of ketones. The study aims to measure changes in specific energy chemicals in your muscles (Phosphocreatine, Adenosine Triphosphate, and Inorganic Phosphate) from the start to three months later. To join, you need to be between 18 and 70 years old, have Type 2 Diabetes, HFrEF, and meet certain blood pressure, BMI, and kidney function (eGFR) requirements. The study plans to enroll 71 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 71 participants. It compares the effects of empagliflozin to a placebo.
What's involved
You would take empagliflozin or a placebo once daily for 3 months. Some participants will also take acipimox for 8 days after the initial 3 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured from baseline to 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06229678

Ketones, SGLT2, HFrEF

Recruiting
EARLY_PHASE1Ages 18–70InterventionalBasic science
The University of Texas Health Science Center at San Antonio
~71 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Empagliflozin 25 MG Oral TabletPlaceboAcipimox 250 Mg Oral Capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Phosphocreatine
Measured over Baseline to 3 months
+4 more outcomes measured

Conditions

Type2diabetes
Heart Failure With Reduced Ejection Fraction

Explore related trials

Heart failure with reduced ejection fractionType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ralph DeFronzo, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Ralph DeFronzo, MD
[email protected]
210-567-6691
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Type 2 Diabetes Mellitus
Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
Age 18-80 years
BMI 23-44 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
Only Type 2 diabetics treated with diet/exercise, metformin, sulfonylureas, metformin/sulfonylurea, Glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin
Stable body weight (±4 pounds) over the previous 3 months prior to enrollment
Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion

Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, hypertrophic obstructive cardiomyopathy.
Significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose or addition of another heart failure medication)
Type 2 Diabetics treated with Dipeptidyl Peptidase-4 Inhibitor (DPP4i) or pioglitazone
Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each MRI study to assess current status. For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.
Allergy/sensitivity to study drugs or their ingredients.
Cancer.
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.

What this trial measures

  • Change in PhosphocreatineBaseline to 3 months

    A measure of phosphocreatine change from baseline to study end

  • Change in Adenosine Triphosphate (ATP)Baseline to 3 months

    A measure of ATP change from baseline to study end

  • Change in Inorganic PhosphateBaseline to 3 months

    A measure of inorganic phosphate change from baseline to study end

  • Change in PhosphodiesterBaseline to 3 months

    A measure of phosphodiester change from baseline to study end

  • ATPmax productionBaseline to 3 months

    Exercise induced ATPmax production change