drugset / Trial / NCT07614230

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

NCT07614230

Phase 4 Recruiting 144 enrolled Junjie Yang
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-01
Primary completion
2027-06-01
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral