Effects of Sodium-Glucose Co-transporter 2 Inhibitors on Inflammation (EFSII)

The Washington University

Status and phase

Completed

Early Phase 1

Conditions

Inflammation

Treatments

Drug: Dapagliflozin (DAPA)

Study type

Interventional

Funder types

Other

Identifiers

NCT06812429

202401169

Details and patient eligibility

About

The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age: ≥18
Patient has no prior history or use of Sodium-Glucose Co-transporter 2 Inhibitors.
Women who are surgically sterilized, amenorrheic for a year, on long-term contraceptives like intrauterine devices and implantable and injectable contraceptives.
Willing and able to complete the outcome assessments.

Exclusion criteria

History of cardiac diseases (Heart Failure, NSTEMI/STEMI, cardiomyopathies, myocarditis).
Diagnosis of Type I Diabetes Mellitus.
Symptomatic hypotension (symptoms of hypotension + Systolic blood pressure < 90).
Estimated glomerular filtration rate <25 mL/minute/1.73 m2, with renal function test done within a year from the study enrollment date.
Alcohol use disorder as defined by the NIAAA or use of controlled substances or smoking cigarettes.
History of dapagliflozin or other Sodium-Glucose Co-transporter 2 Inhibitor sensitivity.
Other concomitant disease or condition that the investigator deems unsuitable for the study, including psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
Women who are pregnant or intend to become pregnant