Can common diabetes drugs shield the heart? AI and Real-World data seek answers
NCT ID NCT07770737
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This observational study looks at whether two classes of diabetes medications—SGLT2 inhibitors and GLP-1 receptor agonists—help protect the heart in Korean adults with type 2 diabetes. Researchers will analyze health records from multiple hospitals to compare heart attack, stroke, and heart failure rates among patients taking these drugs. In a smaller phase, about 100 patients starting an SGLT2 inhibitor will undergo heart imaging, AI-based ECG, and blood tests to see if early changes in heart function can be detected. The study does not assign any treatments; patients receive their usual care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SGLT2 inhibitors and GLP-1 receptor agonists (medications for type 2 diabetes)
- What this could lead to
- If successful, this could clarify which diabetes medications best protect the heart, potentially guiding treatment choices to reduce heart attacks, strokes, and heart failure in people with type 2 diabetes.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. Results may be influenced by other factors, and the small prospective phase may not be generalizable to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Phase 1 will include adults with type 2 diabetes identified from de-identified electronic health records mapped to the OMOP Common Data Model at participating Korean hospitals. New users of SGLT2 inhibitors, GLP-1 receptor agonists, or eligible comparator glucose-lowering medications will be included. Phase 2 will consecutively screen adults aged 50 years or older with type 2 diabetes and cardiovascular or renal risk factors who are scheduled to initiate an SGLT2 inhibitor during routine clinical care at Dongtan Sacred Heart Hospital. Approximately 100 participants will undergo baseline screening, and approximately 50 participants meeting the protocol-defined criteria for the stage B heart failure longitudinal cohort will complete 6-month follow-up assessments.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Phase 1: Retrospective Cohorts Inclusion Criteria: * Adults aged 19 years or older. * Diagnosis of type 2 diabetes mellitus. * New initiation of a study medication, including an SGLT2 inhibitor, a GLP-1 receptor agonist, or another eligible glucose-lowering medication. * At least 180 days of observable data before the index date, defined as the date of the first eligible prescription. Exclusion Criteria: * Type 1 diabetes mellitus or secondary diabetes mellitus. * Use of a medication from the same drug class within 90 days before the index date. * Pregnancy recorded during the relevant study period. * A history of the outcome being evaluated during the baseline period, applied separately for each outcome analysis. Phase 2: Prospective SGLT2 Inhibitor Validation Cohort Inclusion Criteria: * Adults aged 50 years or older receiving outpatient care at Dongtan Sacred Heart Hospital. * Diagnosis of type 2 diabetes mellitus. * No current or previous signs or symptoms of heart failure and New York Heart Association functional class I. * At least one of the following high-risk characteristics: diabetes duration of 5 years or longer, hypertension, body mass index of 25 kg/m² or higher, urinary albumin-to-creatinine ratio of 30 mg/g or higher, estimated glomerular filtration rate below 60 mL/min/1.73 m², or diabetic microvascular complications. * No previous treatment with an SGLT2 inhibitor and scheduled to initiate an SGLT2 inhibitor based on the treating physician's clinical judgment. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Current or previous diagnosis of heart failure, hospitalization for heart failure, clinically suspected signs or symptoms of heart failure, or screening left ventricular ejection fraction below 50%. * Moderate or severe valvular heart disease, known hypertrophic, dilated, or infiltrative cardiomyopathy, complex congenital heart disease, or clinically significant pericardial disease. * Acute coronary syndrome, coronary revascularization, or stroke within 3 months before enrollment. * Presence of a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device. * Atrial fibrillation, sustained tachycardia, frequent premature contractions, or another arrhythmia that prevents reliable comparison of ECG or global longitudinal strain measurements. * Type 1 diabetes mellitus, secondary diabetes mellitus, diabetic ketoacidosis within the previous year, or another clinical condition making SGLT2 inhibitor treatment inappropriate. * Estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis. * Echocardiographic image quality insufficient for reliable 3-view global longitudinal strain or stage B heart failure assessment. * Pregnancy or breastfeeding. * Unwillingness to undergo study assessments or inability to complete the 6-month follow-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450, South Korea
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