Actively Recruiting
Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
Led by Seoul National University Bundang Hospital · Updated on 2026-05-05
56
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Bundang Hospital
Lead Sponsor
D
Daewon Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
- Male or female of 20 years or over
- Mixed dyslipidemia: triglyceride 200~499 mg/dL, HDL-cholesterol male 65 mg/dL or female 60 mg/dL
- Identified carotid artery plaque: carotid intima-media thickness (cIMT) 61 1.0 mm
- Creatinine 641.8 mg/dL
You will not qualify if you...
- Dyslipidemia which requires other therapy: triglyceride 64500 mg/dL or LDL-cholesterol 64190 mg/dL
- Uncontrolled hypertension
- Severe renal dysfunction
- GOT/GPT >120/120 or chronic liver disease
- Pregnant or childbearing woman who does not have enough contraception
- Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months
- Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either choline fenofibrate or policosanol daily to evaluate the effect on carotid atherosclerosis.
Visits scheduled throughout the 24 weeks to monitor progress and collect data
Trial Site Locations
Total: 1 location
1
SNUBH
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
Research Team
S
Soo Lim
M
Minji Sohn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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