Testing empagliflozin and ketone levels in people with diabetes and heart failure
Tests empagliflozin and ketone changes in adults with diabetes and heart failure.
Plain-language title generated from the registry record
Registry title: Ketones, SGLT2, HFrEF
Key facts
- Where
- San Antonio, United StatesSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06229678, who can take part
Where in United States
- Texas Diabetes Institute - University Health SystemSan Antonio, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Texas Health Science Center at San Antonio
- Trial code
- NCT06229678
- Record updated
- 5 February 2026
- Original description
The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic functionRead full original descriptionShow less
Ketones, Muscle Metabolism, and SGLT2 Inhibitors
The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function
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: 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; Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements; Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, hypertrophic obstructive cardiomyopathy; Allergy/sensitivity to study drugs or their ingredients; Cancer; 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; Inability or unwillingness of individual or legal guardian/representative to give written informed consent.