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Lay Description

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

  • Heart, Vascular and Blood
IRB Number
20210528HU
NCT Number
NCT05057806
Open to Enrollment
Yes

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

Arm Groups

Study Contact


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

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

Principal Investigator
Carolina Solis-Herrera