NCT07614230 SGLT2 Inhibitors on Coronary Atherosclerosis Progression Via Perivascular Adipose Tissue in Diabetes
| NCT ID | NCT07614230 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Junjie Yang |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 144 participants in total. It began in 2026-01-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multicenter, randomized controlled trial to test whether an SGLT2 inhibitor (dapagliflozin), a type of diabetes medication, can slow down or even reverse the progression of coronary atherosclerosis (plaque buildup in the coronary arteries) in patients with type 2 diabetes. The effect may be mediated by improving the function of perivascular adipose tissue. A total of 144 adults with type 2 diabetes and stable coronary artery disease will be randomly assigned to receive either dapagliflozin plus standard diabetes and cardiovascular care (intervention group) or standard care alone (control group) for 18 months. Serial coronary CT angiography and other assessments will be performed to evaluate changes in coronary plaque volume, CT-derived fractional flow reserve, perivascular fat radiomics score, and various metabolic and inflammatory markers, to determine whether SGLT2 inhibition reduces cardiovascular risk.
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 75 years. * Confirmed diagnosis of type 2 diabetes mellitus with SCORE2-Diabetes risk score \>10%. * Stable angina pectoris. * Coronary CT angiography (CCTA) demonstrating 50%-90% stenosis in at least one coronary vessel with diameter ≥2.5 mm. * CT-derived fractional flow reserve (CT-FFR) \>0.8 in the target vessel. * Stable standard therapy for diabetes and cardiovascular disease, with no changes in SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors within the past 4 weeks. * Able and willing to provide written informed consent. Exclusion Criteria: * History of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) with stenting, prosthetic valve replacement, or permanent pacemaker implantation. * New York Heart Association (NYHA) functional class III or IV heart failure. Acute myocardial infarction within the previous 30 days. * Known allergy to iodinated contrast media or other contraindications to CCTA. Severe arrhythmia or coronary artery calcium (CAC) score \>400. * Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². History of serious adverse reactions to SGLT2 inhibitors. * Pregnancy, lactation, or planned pregnancy during the study period. Severe liver dysfunction (Child-Pugh class C). * Any other condition that, in the investigator's opinion, makes the participant unsuitable for the trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07614230 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 78 Years, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07614230 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07614230 currently recruiting?
Yes, NCT07614230 is actively recruiting participants. Contact the research team at fearlessyang@126.com for enrollment information.
Where is the NCT07614230 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT07614230 clinical trial?
NCT07614230 is sponsored by Junjie Yang. The trial plans to enroll 144 participants.
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