NCT06229678RecruitingEarly phase 1
Ketones, SGLT2, HFrEF
Ketones, Muscle Metabolism, and SGLT2 Inhibitors
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 71 (estimated)
- First submitted
- 18 Dec 2023
- Start date
- 25 Jan 2024
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Heart failure
- NCT number
- NCT06229678
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 71
- From 25 Jan 2024 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Age
- 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.
Other
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Diabetes Institute - University Health System Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.