SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Empagliflozin 25 MG
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
Doris Duke Charitable Foundation
Collaborator
Max and Minnie Tomerlin Voelcker Fund
Collaborator
Source ClinicalTrials.gov