| NCT ID | NCT06229678 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Type2diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 71 participants |
| Start Date | 2024-01-25 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 71 participants in total. It began in 2024-01-25 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Ralph DeFronzo, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT06229678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Type2diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06229678 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06229678 currently recruiting?
Yes, NCT06229678 is actively recruiting participants. Contact the research team at defronzo@uthscsa.edu for enrollment information.
Where is the NCT06229678 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT06229678 clinical trial?
NCT06229678 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Ralph DeFronzo, MD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 71 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.