Purpose

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.

Category

IRB Number
20210528HU
NCT Number
NCT05057806
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Principal Investigator
Carolina Solis-Herrera

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu



Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    • 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
    • Stable body weight (±4 pounds) over the last 3 months

Exclusion Criteria

    • Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
    • Resting heart rate >120 bpm
    • Systolic BP>180mmHg and/or diastolic BP >100mmHg
    • Resting percentage of blood oxygen saturation (SpO2) < 85%
    • Physical disability preventing safe performance of the exercise protocol.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A randomized (2:1) placebo controlled double blind study
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)
Masking Description
Participants and investigators will be blinded to the randomization.
Condition
  • Type2 Diabetes
  • Heart Failure With Preserved Ejection Fraction

    • Arm Groups

    ArmDescriptionIntervention
    Placebo Comparator

    Placebo group

    		Subjects will be randomized to receive the empagliflozin placebo for 3 months
  • Drug: Placebo

    The placebo will be administered orally once per day for 3 months

    Other names:

    • Placebo for Empagliflozin

    • Experimental

    Empagliflozin Group

    		Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months
  • Drug: Empagliflozin 25 MG

    Empagliflozin 25MG will be administered orally once per day for 3 months

    Other names:

    • Jardiance

    •