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Clinical Trials in China / NCT07614230
Recruiting Phase 4

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

NCT07614230 · tracked via the Priya Life Science China tracker
Sponsor
Junjie Yang
Phase
Phase 4
Started
2026-01-01
Last updated
2026-05-29

Condition(s) studied

Type 2 Diabetes Mellitus (T2DM)Coronary Artery DiseaseAtherosclerosis

Investigational drug(s) / intervention(s)

Dapagliflozin (DAPA) →Standard Care (Treatment as Usual)

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.

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
78 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression of Coronary Plaque Volume and Proportion from Baseline to the 18-Month Follow-Up — Baseline to 18 months
    Progression of total plaque volume (TPV) （mm³）from baseline or appearance of new plaques, assessed by coronary CT angiography (CCTA). Includes changes in plaque components (e.g., necrotic core, fibrous cap, calcification)（mm³）.

Trial sites (2)

FacilityCityRegionStatus
The First Medical Center of Chinese PLA General Hospital Beijing Beijing Municipality Recruiting
The Sixth Medical Center of Chinese PLA General Hospital Beijing Beijing Municipality Recruiting

Other trials for the same condition

IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions Active, not recruiting
An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes Recruiting
The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment Recruiting
Prospective Study Protocol for Multiparametric PCCT Assessment of Early Ventricular Outcomes After CABG Recruiting
Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07614230 on ClinicalTrials.gov ↗ ← All trials in China