Effects of SGLT2 Inhibitors and Ketones on Heart and Muscle Health
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
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 |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT05057806 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with Type 2 Diabetes and Class II-III heart failure with reduced ejection fraction.
Not a fit: Patients with severe claustrophobia, contraindications for MRI, or those currently on certain diabetes medications may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Antonio, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.