Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1

Completed · Phase 1

Conditions studied: Heart Failure, Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT03560323

Run by

The University of Texas Health Science Center at San Antonio

People needed

41

Starts

2019-01-07

Expected to finish

2024-12-30

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 145/85 mmHg.
• eGFR > 30 mL/min/1.73 m2.
• NT-proBNP ≥ 500 pg/mL (or ≥ 300 pg/mL if ejection fraction is less than 35 %).

You may not qualify if…

• 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.

Where it is running

• Texas Diabetes Institute - University Health System — San Antonio, Texas, United States
• University of Texas Health Science Center San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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