Search / Trial NCT06229678

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Ketones Cardiovascular Benefit

Description

The study team will examine the effects of elevated plasma ketones caused by 12-week treatment with an SGLT2i (empagliflozin) treatment in participants with T2DM and HF. The study team will focus on three possible mechanisms of action for these effects and test the following: (i) Skeletal muscle bioenergetics. Using 31P-MRS, the team will quantify phosphocreatine \[PCr\], ATP, inorganic phosphate, phosphodiester, and intracellular pH. With 1H-MRS, and will measure intramyocellular lipid content at rest and ATPmax production after exercise. The team will examine the relationships between ph...

Gender

ALL

Eligibility criteria

  • 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.

About The University Of Texas Health Science Center At San Antonio

The University of Texas Health Science Center at San Antonio (UT Health San Antonio) is a leading academic medical institution dedicated to advancing health through education, research, and patient care. As a prominent sponsor of clinical trials, UT Health San Antonio focuses on innovative medical research aimed at improving health outcomes across diverse populations. With a commitment to excellence, the institution fosters collaboration among its multidisciplinary teams to explore cutting-edge therapies and interventions. Through rigorous scientific inquiry and ethical practices, UT Health San Antonio strives to make meaningful contributions to the field of medicine and enhance the quality of life for patients.

Locations

San Antonio, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0