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SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
RECRUITINGEarly 1Sponsored by The University of Texas Health Science Center at San Antonio
Actively Recruiting
PhaseEarly 1
SponsorThe University of Texas Health Science Center at San Antonio
Started2021-01-13
Est. completion2026-11-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05057806
Summary
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.
Eligibility
Age: 18 Years – 80 YearsHealthy volunteers accepted
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
Conditions4
DiabetesHeart DiseaseHeart Failure With Preserved Ejection FractionType2 Diabetes
Locations2 sites
Texas Diabetes Institute - University Health System
San Antonio, Texas, 78207
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
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Actively Recruiting
PhaseEarly 1
SponsorThe University of Texas Health Science Center at San Antonio
Started2021-01-13
Est. completion2026-11-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05057806