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Empagliflozin for Type 2 Diabetes and Heart Failure

This study is looking at how empagliflozin, a medication, affects people with Type 2 Diabetes and a type of heart failure called Heart Failure with Preserved Ejection Fraction. Researchers want to understand how empagliflozin, and the ketones it can produce, impact your muscles and heart. They will measure changes in important energy chemicals in your body, like Phosphocreatine and Adenosine Triphosphate (ATP), over 3 months. You might be able to join if you are 18-80 years old, have Type 2 Diabetes, and certain heart failure criteria. The study aims to enroll 30 participants and is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 30 participants. It compares empagliflozin to a placebo (an inactive pill).
What's involved
Participants will take either empagliflozin or a placebo orally once per day for 3 months. Specific visits or procedures are not detailed.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study are taken from the beginning (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.

NCT05057806

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Recruiting
EARLY_PHASE1Ages 18–80InterventionalBasic science
The University of Texas Health Science Center at San Antonio
~30 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Empagliflozin 25 MGPlacebo

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

Type2 Diabetes
Heart Failure With Preserved Ejection Fraction

Explore related trials

Heart FailureType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Carolina Solis-Herrera, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Carolina Solis-Herrera, MD
[email protected]
210-567-4900
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 23-38 kg/m2
Glycated hemoglobin (HbA1c) 5.5-10%
Blood Pressure (BP) ≤ 145/85 mmHg
Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
Stable dose of guideline-directed medications for heart failure and Diabetes
Stable body weight (±4 pounds) over the last 3 months
Does not suffer from severe claustrophobia
No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Exclusion

Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
Pregnancy, lactation or plans to become pregnant
Allergy/sensitivity to study drugs or their ingredients
Cancer
Current drug or alcohol use or dependence
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