Effects of Sodium-Glucose Co-transporter 2 Inhibitors on Inflammation
NCT ID: NCT06812429
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
6 participants
INTERVENTIONAL
2024-05-08
2025-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Dapagliflozin group
Participants in this arm receive dapagliflozin 10mg for three days.
Dapagliflozin (DAPA)
Participants will receive 10mg of Dapagliflozin per day for three days.
Interventions
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Dapagliflozin (DAPA)
Participants will receive 10mg of Dapagliflozin per day for three days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Amanda Verma
Assistant Professor of Medicine, Principal Investigator
Locations
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Washington University
St Louis, Missouri, United States
Countries
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References
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USE OF SGLT2 INHIBITORS IN THE MANAGEMENT OF PATIENTS WITH HEART FAILURE POCKET GUIDE.
Bonnet F, Scheen AJ. Effects of SGLT2 inhibitors on systemic and tissue low-grade inflammation: The potential contribution to diabetes complications and cardiovascular disease. Diabetes Metab. 2018 Dec;44(6):457-464. doi: 10.1016/j.diabet.2018.09.005. Epub 2018 Sep 26.
Cardiac And Kidney Benefits Of Dapagliflozin Are Associated With ApoM Levels In Patients With Heart Failure With Reduced Ejection Fraction
Cowie MR, Fisher M. SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control. Nat Rev Cardiol. 2020 Dec;17(12):761-772. doi: 10.1038/s41569-020-0406-8. Epub 2020 Jul 14.
Chirinos JA, Zhao L, Jia Y, Frej C, Adamo L, Mann D, Shewale SV, Millar JS, Rader DJ, French B, Brandimarto J, Margulies KB, Parks JS, Wang Z, Seiffert DA, Fang J, Sweitzer N, Chistoffersen C, Dahlback B, Car BD, Gordon DA, Cappola TP, Javaheri A. Reduced Apolipoprotein M and Adverse Outcomes Across the Spectrum of Human Heart Failure. Circulation. 2020 May 5;141(18):1463-1476. doi: 10.1161/CIRCULATIONAHA.119.045323. Epub 2020 Apr 2.
Other Identifiers
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202401169
Identifier Type: -
Identifier Source: org_study_id
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