Effects of SGLT2 inhibitors on inflammation

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

This study is testing if a diabetes medication called Dapagliflozin can help reduce inflammation in adults with heart and kidney issues who haven't used this type of medication before.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Washington University School of Medicine (Academic / other)
• Locations: 1 site (Saint Louis, Missouri)
• Trial ID: NCT06812429 on ClinicalTrials.gov

What this trial studies

This research investigates how Sodium-glucose co-transporter 2 (SGLT2) inhibitors, specifically Dapagliflozin, influence inflammation related to cardiorenal health. The study aims to enroll adult participants who have not previously used SGLT2 inhibitors and are willing to complete outcome assessments. By examining the effects of this medication, the study seeks to provide insights into its potential benefits for managing inflammation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older without a history of using SGLT2 inhibitors.

Not a fit: Patients with a history of cardiac diseases, Type I Diabetes Mellitus, or significant renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients suffering from inflammation-related conditions.

How similar studies have performed: While the specific effects of SGLT2 inhibitors on inflammation are still being explored, similar studies have shown promising results in related areas.

Eligibility criteria

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

Where this trial is running

Saint Louis, Missouri

• Washington University — Saint Louis, Missouri, United States (Recruiting)

Study contacts

• Study coordinator: Amen Bekele Zelleke

Conditions Inflammation; SGLT2 inhibitors; Dapagliflozin