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Recruiting Phase 4

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

About this study

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

Condition
Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2
Tested
Choline fenofibrate, Policosanol
Sponsor
Seoul National University Bundang Hospital

Who can join

Age
20 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 20 years
  • Study condition: Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2
  • 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 7

  • 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

1 site, 1 recruiting

SNUBH

Seongnam-si, Gyeonggi-do, South Korea

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.