Effects of SGLT2 Inhibitors and Ketones on Heart and Muscle Health
Official title: Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Run by The University of Texas Health Science Center at San Antonio · NCT05057806 · Data updated 2026-11-12
This study is testing if a diabetes medication can change ketone levels in people with Type 2 Diabetes and heart failure to see how it affects their heart and muscle health over 12 weeks.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Status | Recruiting |
| Started | January 13, 2021 |
| Main results expected | November 30, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT05057806 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-80 with Type 2 Diabetes and Class II-III heart failure with reduced ejection fraction.
✕Probably not a fit
Patients with severe claustrophobia, contraindications for MRI, or those currently on certain diabetes medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how SGLT2 inhibitors, specifically empagliflozin, influence ketone levels in patients with Type 2 Diabetes and heart failure. Over a 12-week period, researchers will assess the impact of elevated plasma ketones on skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported outcomes. The study employs advanced imaging techniques to measure metabolic changes and aims to understand the relationship between ketone uptake and physical function improvements.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with Type 2 Diabetes and heart failure, enhancing their physical function and quality of life.
How similar studies have gone: While the specific combination of SGLT2 inhibitors and ketone effects is novel, similar studies have shown promising results in improving cardiovascular outcomes in diabetic patients.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States Recruiting
Study contacts
- Principal investigator: Carolina Solis-Herrera, MD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Carolina Solis-Herrera, MD
- Email: solisherrera@uthscsa.edu
- Phone: 210-567-4900
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Remote rehabilitation for HFpEF patients using telerehabilitation
A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.
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EDG-15400 in adults with HFpEF: a phase 2 study
This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.
-
Incretin therapy with tirzepatide for obesity-related HFpEF
A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.
-
Boosted exercise with group coaching for HFpEF
This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.
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Exercise cardiac MRI for heart failure with preserved ejection fraction
This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.
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HRS-1893 for heart failure with preserved ejection fraction
This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.