SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Type2 Diabetes, Heart Failure With Preserved Ejection Fraction

In brief

The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.

Key facts

Study ID

NCT05057806

Run by

The University of Texas Health Science Center at San Antonio

People needed

30

Starts

2021-01-13

Expected to finish

2027-03-31

Last updated by the study team

2026-04-06

Who can join

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

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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