Print

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

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

Francisca Acosta
210-562-4094
acostafm@uthscsa.edu

Principal Investigator
Carolina Solis-Herrera