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

January 4, 2026 updated by: Amanda Verma, Washington University School of Medicine
The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin group
Participants in this arm receive dapagliflozin 10mg for three days.
Drug: Dapagliflozin (DAPA)
Participants will receive 10mg of Dapagliflozin per day for three days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the markers of Inflammation at three days
Time Frame: From enrollment to the end of treatment at 3 days.
From enrollment to the end of treatment at 3 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Actual)

April 5, 2025

Study Completion (Actual)

April 5, 2025

Study Registration Dates

First Submitted

February 1, 2025

First Submitted That Met QC Criteria

February 1, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202401169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Dapagliflozin (DAPA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe