Recruiting

SGLT2 Inhibitors on Coronary Atherosclerosis Progression Via Perivascular Adipose Tissue in Diabetes

ClinicalTrials.gov IDNCT07614230

PhasePHASE4

Enrollment144

SponsorJunjie Yang

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes Mellitus (T2DM), Coronary Artery Disease, Atherosclerosis

About this study

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.

Interventions

Drug: Dapagliflozin (DAPA) — Dapagliflozin 10 mg tablet administered orally once daily for 18 months, in addition to standard diabetes and cardiovascular care, to evaluate its effects on coronary atherosclerosis progression mediated by perivascular adipose tissue in patients with type 2 diabetes.
Other: Standard Care (Treatment as Usual) — Standard glycemic and cardiovascular management according to clinical guidelines, excluding SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors, for 18 months.

Primary outcomes

Progression of Coronary Plaque Volume and Proportion from Baseline to the 18-Month Follow-Up (Baseline to 18 months)

Eligibility information

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.

Study locations

The First Medical Center of Chinese PLA General Hospital, Beijing, Beijing Municipality China
The Sixth Medical Center of Chinese PLA General Hospital, Beijing, Beijing Municipality China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.