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

Sponsor
Dongtan Sacred Heart Hospital
Study ID
NCT07770737
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Diseases
  • Stage B Heart Failure
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Retrospective SGLT2 Inhibitor Cohort
    Patients with type 2 diabetes who initiated an SGLT2 inhibitor and were identified retrospectively from multicenter OMOP Common Data Model databases.
  • Arm: Retrospective GLP-1 Receptor Agonist Cohort
    Patients with type 2 diabetes who initiated a GLP-1 receptor agonist and were identified retrospectively from multicenter OMOP Common Data Model databases.
  • Arm: Prospective SGLT2 Inhibitor Validation Cohort
    Adults with type 2 diabetes who are newly starting an SGLT2 inhibitor and undergo baseline cardiovascular assessments. Approximately 50 participants meeting the protocol-defined criteria for stage B heart failure will undergo repeat AI-ECG, electrocardiographic, echocardiographic, laboratory, and body composition assessments after 6 months.

Primary Outcome Measure

Time to First Atherosclerotic Cardiovascular Disease Composite Event [ Time Frame: From the index date until the first occurrence of acute myocardial infarction or ischemic stroke, loss to follow-up, death, or the end of available database records, whichever occurs first, assessed up to 12 years ]

Central Contacts

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