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

Recruiting now · Phase 4

Conditions studied: Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2

In brief

This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.

Key facts

Study ID

NCT05365425

Run by

Seoul National University Bundang Hospital

People needed

56

Starts

2023-06-01

Expected to finish

2027-12-31

Last updated by the study team

2026-05-05

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≤45 mg/dL or female ≤50 mg/dL
• Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
• Creatinine ≤1.8 mg/dL

You may not qualify if…

• Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 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)

Where it is running

• SNUBH — Seongnam-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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