Effect of choline fenofibrate on carotid atherosclerosis in type 2 diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled study evaluates the impact of choline fenofibrate compared to policosanol on carotid atherosclerosis in Korean patients with type 2 diabetes and combined dyslipidemia. The study focuses on assessing changes in carotid intima-media thickness and plaque formation using 3D carotid ultrasound. Participants will be monitored for their response to treatment over a specified period, aiming to determine the efficacy of choline fenofibrate in slowing disease progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Snubh
  Seongnam-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Soo Lim
• Email: limsoo@snu.ac.kr
• Phone: +82-31-787-7035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.