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NCT07770737

Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes

Sponsor: Dongtan Sacred Heart Hospital

View on ClinicalTrials.gov

Summary

This observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists) in Korean adults with type 2 diabetes. The study consists of two phases. Phase 1 will use de-identified electronic health record data from multiple Korean hospitals organized in a common data model. Cardiovascular outcomes, including myocardial infarction, ischemic stroke, and hospitalization for heart failure, will be compared among patients who started an SGLT2 inhibitor or a GLP-1 receptor agonist. Fractures, metabolic changes, and real-world medication use will also be evaluated. Phase 2 will prospectively enroll approximately 100 adults with type 2 diabetes who are starting an SGLT2 inhibitor as part of routine clinical care at Dongtan Sacred Heart Hospital. Participants will undergo electrocardiography, AI-based ECG analysis, echocardiography, blood and urine tests, and body composition assessment at baseline. Approximately 50 participants with stage B heart failure, defined as structural or functional heart abnormalities without heart failure symptoms, will undergo the same assessments after 6 months. The primary outcome of Phase 2 is the change in echocardiographic global longitudinal strain from baseline to 6 months. The study will also examine whether changes detected by AI-based ECG are associated with changes in echocardiographic measures of cardiac function. The study does not assign medications or alter routine treatment. All treatment decisions are made by the participants' treating physicians.

Official title: Evaluation of Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes: A Multicenter CDM-Based Retrospective Cohort Study With Prospective AI-ECG Validation

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-09

Completion Date

2027-12-31

Last Updated

2026-08-18

Healthy Volunteers

No

Locations (1)

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea