Study of Atorvastatin and Omega-3 Combination Therapy to Treat Carotid Artery Disease in Adults With Type 2 Diabetes and Mixed Dyslipidemia

What this Trial Is About

Researchers are evaluating the effects of combining atorvastatin and omega-3 compared to atorvastatin and ezetimibe in Korean patients with type 2 diabetes who have asymptomatic atherosclerosis and combined dyslipidemia. This phase 4 randomized controlled study aims to understand how these treatments influence the progression of carotid artery thickness and plaque, important markers of cardiovascular health. The study is sponsored by Seoul National University Bundang Hospital. Participants will be assigned to one of three treatment groups one receiving Atmeg capsules each containing atorvastatin 10 mg and omega-3 1000 mg along with Omethyl Cutielet omega-3 supplement once daily one receiving just Atmeg capsules twice daily and one receiving a tablet of atorvastatin 20 mg combined with ezetimibe 10 mg once daily. The treatment period lasts 24 weeks, during which the effects on carotid arteries will be closely monitored using 3D carotid ultrasound. During the study, participants will undergo assessments including carotid intima media thickness, carotid plaque area and characteristics, blood glucose control, lipid levels, body composition by bioelectrical impedance, proteinuria, and changes in gut microbiota. These evaluations are conducted at the start and completion of the 24-week treatment. Safety and adherence will be monitored throughout the trial, which enrolls adults aged 20 to 80 years with specific lipid and diabetes criteria.

Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia