NCT05057806 SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
| NCT ID | NCT05057806 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Type2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-01-13 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 30 participants in total. It began in 2021-01-13 with a primary completion date of 2026-11-30.
⚠ 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 SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.
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 23-38 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 Criteria: * 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
Contact & Investigator
Carolina Solis-Herrera, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT05057806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Type2 Diabetes. 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 NCT05057806 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 NCT05057806 currently recruiting?
Yes, NCT05057806 is actively recruiting participants. Contact the research team at solisherrera@uthscsa.edu for enrollment information.
Where is the NCT05057806 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT05057806 clinical trial?
NCT05057806 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Carolina Solis-Herrera, MD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 30 participants.
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