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

Early Phase 1

Recruiting

• Conditions: Inflammation
• Interventions: Drug: Dapagliflozin (DAPA)

• Registration Number: NCT06812429
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-08
• Status Verified: 2025-02
• Study First Submitted: 2025-02-01
• Study First Submitted QC: 2025-02-01
• Study First Posted: 2025-02-06
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapagliflozin group	Dapagliflozin (DAPA)	Participants in this arm receive dapagliflozin 10mg for three days.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the markers of Inflammation at three days	From enrollment to the end of treatment at 3 days.

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States