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SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

RecruitingEARLY Phase 1Ages 18 Years - 80 YearsAllThe University of Texas Health Science Center at …
NCT05057806 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 and Diabetes * Stable body weight (±4 pounds) over the last 3 months * Does not suffer from severe claustrophobia * No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker) Exclusion Criteria: * 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 * Current drug or alcohol use or dependence * Inability or unwillingness of individual or legal guardian/representative to give written informed consent
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What it tests

  • Empagliflozin 25 MG
  • Placebo
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Where

1 site
University of Texas Health Science Center at San Antonio
San Antonio, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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