drugset / Trial / NCT03560323
Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1
Phase 1
Completed
41 enrolled
The University of Texas Health Science Center at San Antonio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
Non-randomizedSingle-groupOpen-labelBasic science
Summary
To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii) myocardial glucose uptake using positron emission tomography (PET) with 18F-fluoro-2-deoxy-D-glucose in type 2 diabetic patients with Class II-III New York Heart Association (NYHA).
Timeline
- Start
- 2019-01-07
- Primary completion
- 2024-08-30
- Completion
- 2024-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 3-HYDROXYBUTYRIC ACID, (+/-)- | Small molecule | 0.2 mg/kg | — |
| Comparator | 3-HYDROXYBUTYRIC ACID, (+/-)- | Small molecule | 0.75 mg/kg | — |
| Comparator | 3-HYDROXYBUTYRIC ACID, (+/-)- | Small molecule | 2 mg/kg | — |