Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Recruiting · NCT05365425 · Interventional (participants receive a specific treatment) · Lead sponsor: Seoul National University Bundang Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Choline fenofibratePolicosanol
What this trial is about
This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
Who can take part
Age range
20 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →