Effects of ketones on heart function in diabetic patients
Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1.
PHASE1 · The University of Texas Health Science Center at San Antonio · NCT03560323
This study is testing if different levels of ketones can help improve heart function and glucose use in people with type 2 diabetes and heart failure.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio (other) |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Trial ID | NCT03560323 on ClinicalTrials.gov |
What this trial studies
This study investigates how varying levels of beta-hydroxy-butyrate (B-OH-B) affect heart function and glucose metabolism in patients with type 2 diabetes and heart failure. Participants will undergo cardiac MRI and PET scans to assess left ventricular function and myocardial glucose uptake. The study aims to explore the 'ketone hypothesis,' which suggests that ketones may improve heart function and reduce cardiovascular risks in diabetic patients. Eligible participants will be closely monitored for changes in cardiac parameters and metabolic markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with type 2 diabetes and NYHA Class II-III heart failure and an ejection fraction of less than 50%.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and reduced cardiovascular risks for patients with type 2 diabetes and heart failure.
How similar studies have performed: Previous studies have shown promising results regarding the effects of SGLT2 inhibitors on cardiovascular outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Type 2 diabetes. 2. Class II-III New York Heart Association (NYHA) heart failure with ejection fraction less than 50 %. 3. Age 18-80 years. 4. BMI 23-38 kg/m2. 5. HbA1c 6.0-9.0 %. 6. Blood pressure \< 145/85 mmHg. 7. eGFR \> 30 mL/min/1.73 m2. 8. NT-proBNP ≥ 500 pg/mL (or ≥ 300 pg/mL if ejection fraction is less than 35 %). Exclusion Criteria: 1. Treatment with Glucagon-like peptide-1 receptor agonist (GLP-1 RA), Dipeptidyl peptidase-4 inhibitors (DPP4i), pioglitazone, SGLT2 inhibitor or insulin. 2. Women who are pregnant or breastfeeding. 3. Contraindications for MRI include metal plates, parts, screws, shrapnel, pins in the body, or cardiac pacemaker. 4. Any other condition that in the opinion of the investigator create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results.
Where this trial is running
San Antonio, Texas and 1 other locations
- Texas Diabetes Institute - University Health System — San Antonio, Texas, United States (RECRUITING)
- University of Texas Health Science Center San Antonio — San Antonio, Texas, United States (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Ralph A DeFronzo, MD — UT Health San Antonio
- Study coordinator: Ralph A. DeFronzo, MD
- Email: defronzo@uthscsa.edu
- Phone: 210-567-6691
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.
Conditions: Heart Failure, Type 2 Diabetes Mellitus, Ketone Body Metabolism, Myocardial Glucose Uptake, Positron Emission Tomography, Myocardial Function