NCT06812429

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2024

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

February 1, 2025

Last Update Submit

January 4, 2026

Conditions

Inflammation

Keywords

SGLT2 inhibitorsDapagliflozinInflammation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the markers of Inflammation at three days

    From enrollment to the end of treatment at 3 days.

Study Arms (1)

Dapagliflozin group

EXPERIMENTAL

Participants in this arm receive dapagliflozin 10mg for three days.

Drug: Dapagliflozin (DAPA)

Interventions

Dapagliflozin (DAPA)DRUG

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

Dapagliflozin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

  • USE OF SGLT2 INHIBITORS IN THE MANAGEMENT OF PATIENTS WITH HEART FAILURE POCKET GUIDE.

    BACKGROUND

  • 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.

    PMID: 30266577BACKGROUND

  • Cardiac And Kidney Benefits Of Dapagliflozin Are Associated With ApoM Levels In Patients With Heart Failure With Reduced Ejection Fraction

    BACKGROUND

  • 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.

    PMID: 32665641BACKGROUND

  • 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.

    PMID: 32237898BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Principal Investigator

Study Record Dates

First Submitted

February 1, 2025

First Posted

February 6, 2025

Study Start

May 8, 2024

Primary Completion

April 5, 2025

Study Completion

April 5, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

US(1)