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RECRUITING
NCT07614230
PHASE4

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

Sponsor: Junjie Yang

View on ClinicalTrials.gov

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.

Official title: Effects of SGLT2 Inhibitors on Coronary Atherosclerosis Progression in Diabetes Mediated by Perivascular Adipose Tissue: The SCOPE Trial

Key Details

Gender

All

Age Range

18 Years - 78 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2026-01-01

Completion Date

2028-12-31

Last Updated

2026-05-29

Healthy Volunteers

No

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.

Locations (2)

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