Effect of choline fenofibrate on carotid atherosclerosis in type 2 diabetes patients
Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
This study is testing if a medication called choline fenofibrate can help slow down the buildup of plaque in the arteries of Korean patients with type 2 diabetes and high cholesterol.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT05365425 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and over with type 2 diabetes, mixed dyslipidemia, and identified carotid artery plaque.
Not a fit: Patients with severe dyslipidemia requiring other therapies or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to slow the progression of atherosclerosis in patients with type 2 diabetes and dyslipidemia.
How similar studies have performed: Other studies have shown promise in using similar lipid-modifying agents for cardiovascular benefits, but this specific approach with choline fenofibrate is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seongnam-si, Gyeonggi-do
- Snubh — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Soo Lim
- Email: limsoo@snu.ac.kr
- Phone: +82-31-787-7035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.