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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06812429
Acronym
EFSII
Enrollment
6
Registered
2025-02-06
Start date
2024-05-08
Completion date
2025-04-05
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

SGLT2 inhibitors, Dapagliflozin, Inflammation

Brief summary

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

Interventions

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

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in the markers of Inflammation at three daysFrom enrollment to the end of treatment at 3 days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026