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

Sponsor
Junjie Yang
Study ID
NCT07614230
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 78 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (DAPA) — DRUG
    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) — OTHER
    Standard glycemic and cardiovascular management according to clinical guidelines, excluding SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors, for 18 months.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SGLT2 Inhibitor Group
    Participants with type 2 diabetes and coronary atherosclerosis receive dapagliflozin 10 mg orally once daily in addition to standard diabetes care for 18 months.
  • Active Comparator: Control Group
    Participants receive standard diabetes care without SGLT2 inhibitors for 18 months.

Primary Outcome Measure

Progression of Coronary Plaque Volume and Proportion from Baseline to the 18-Month Follow-Up [ Time Frame: Baseline to 18 months ]

Central Contacts

Related Studies