Study of Choline Fenofibrate for Treating Carotid Atherosclerosis in Adults with Type 2 Diabetes and Combined Dyslipidemia

What this Trial Is About

Researchers are evaluating the effects of choline fenofibrate compared with policosanol in Korean patients with type 2 diabetes and combined dyslipidemia who also have asymptomatic atherosclerosis. The study focuses on how these treatments impact the progression of carotid artery thickness and plaque using advanced 3D carotid ultrasound imaging. This is a phase 4 randomized controlled trial sponsored by Seoul National University Bundang Hospital. Participants will be randomly assigned to receive either choline fenofibrate 135 mg as fenofibric acid once daily or policosanol 10 mg once daily, both taken orally regardless of diet. The trial lasts 24 weeks, during which researchers will monitor changes in carotid intima media thickness and plaque characteristics to assess the impact of each drug on atherosclerosis progression. Throughout the 24-week study, participants will undergo regular assessments including 3D carotid ultrasound, blood tests for glucose and lipid metabolism, proteinuria checks, bioelectrical impedance analysis, and evaluation of gut microbiota changes. Researchers will carefully track treatment effects and safety to understand how these drugs influence vascular and metabolic health in this population.

Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia