Health TrialsbyHealthPanel

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

ConditionsType 2 Diabetes Mellitus (T2DM)Coronary Artery DiseaseAtherosclerosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-78
SponsorJunjie Yang

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Standard glycemic and cardiovascular management according to clinical guidelines, excluding SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors, for 18 months.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: SGLT2 Inhibitor GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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）.

Time frame
Baseline to 18 months

Secondary outcomes

1

Change in the Coronary Perivascular Fat Radiomics Score (FRS) from Baseline to 18 Months

Change from baseline to the 18-month follow-up in the coronary perivascular fat radiomics score (FRS), measured in "points", where a higher score indicates a higher inflammatory activity state and a stronger correlation with the risk of major adverse cardiovascular events.

Time frame
Baseline to 18 months
2

Change in CT-derived fractional flow reserve (CT-FFR) from Baseline to 18 Months

Change from baseline to the 18-month follow-up in CT-derived fractional flow reserve (CT-FFR), expressed as a pure number between 0 and 1 (no units), where a higher value indicates a lower likelihood of ischemia.

Time frame
Baseline to 18 months
3

Change in Fat Attenuation Index （FAI）from Baseline to 18 Months

Change from baseline to the 18-month follow-up in fat attenuation index (FAI)(HU) .FAI is defined as the mean attenuation value of pericoronary adipose tissue observed on CT scan, ranging from approximately -190 to -30 HU. Higher values indicating increased perivascular adipose tissue inflammation and coronary vulnerability, and lower values suggesting a more stable, anti-inflammatory vascular state.

Time frame
Baseline to 18 months
4

Change in the Degree of Coronary Artery Stenosis from Baseline to 18 Months

Change from baseline to the 18-month follow-up in the degree of coronary artery stenosis, expressed as CAD-RADS category or quantitatively measured percent stenosis. CAD-RADS grades range from 0 to 5, with higher grades indicating greater stenosis severity. Quantitatively measured percent stenosis ranges from 0% to 100%, with higher percentages indicating greater stenosis severity.

Time frame
Baseline to 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Junjie Yang

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now