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OpenTrials
Completed

NCT Number: NCT06812429

Effects of Sodium-Glucose Co-transporter 2 Inhibitors on Inflammation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin (DAPA)

Drug

Participants will receive 10mg of Dapagliflozin per day for three days.

Primary outcomes

  1. Change from baseline in the markers of Inflammation at three days

    Time frame: From enrollment to the end of treatment at 3 days.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: EFSII

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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