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SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
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.
Conditions:
🦠 Type2 Diabetes 🦠 Heart Failure With Preserved Ejection Fraction
🗓️ Study Start (Actual) 13 January 2021
🗓️ Primary Completion (Estimated) 30 November 2026
✅ Study Completion (Estimated) 31 March 2027
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 San Antonio, Texas, United States
📍 San Antonio, Texas, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 September 2021
  • First Submitted that Met QC Criteria 15 September 2021
  • First Posted 27 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 January 2024
  • Last Update Posted 5 January 2024
  • Last Verified January 2024
I'm interested ...!!