Phase 1
N=40
Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1
Heart Failure · Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03560323 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Cardiac Output (CO) — 5.02; 4.54; 5.93; 5.10 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Beta-hydroxy-butyrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Output (CO) |
5.02; 4.54; 5.93; 5.10; 5.3; 7.16 | — |
| PRIMARY Ejection Fraction (EF) |
0.1; 3.9; 6.4 | — |
| PRIMARY Left Ventricular Stroke Volume (LVSV) |
0.3; 9.7; 19.4 | — |
| SECONDARY Myocardial Energetics-Myocardial Glucose Uptake (MGU) |
9.6; 8.56 | — |
| SECONDARY Myocardial Energetics- Myocardic Blood Flow (MBF) |
0.05 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes.
- Class II-III New York Heart Association (NYHA) heart failure with ejection fraction less than 50 %.
- Age 18-80 years.
- BMI 23-38 kg/m2.
- HbA1c 6.0-9.0 %.
- Blood pressure 30 mL/min/1.73 m2.
- NT-proBNP ≥ 500 pg/mL (or ≥ 300 pg/mL if ejection fraction is less than 35 %).
Exclusion Criteria
- Treatment with Glucagon-like peptide-1 receptor agonist (GLP-1 RA), Dipeptidyl peptidase-4 inhibitors (DPP4i), pioglitazone, SGLT2 inhibitor or insulin.
- Women who are pregnant or breastfeeding.
- Contraindications for MRI include metal plates, parts, screws, shrapnel, pins in the body, or cardiac pacemaker.
- 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.
Data sourced from ClinicalTrials.gov (NCT03560323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.