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Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
RECRUITINGPhase 4Sponsored by Seoul National University Bundang Hospital
Actively Recruiting
PhasePhase 4
SponsorSeoul National University Bundang Hospital
Started2023-06-01
Est. completion2025-12-31
Eligibility
Age20 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05365425
Summary
This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
Eligibility
Age: 20 Years+Healthy volunteers accepted
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)
Conditions4
AtherosclerosisDiabetesDiabetes Mellitus, Type 2Dyslipidemia
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Actively Recruiting
PhasePhase 4
SponsorSeoul National University Bundang Hospital
Started2023-06-01
Est. completion2025-12-31
Eligibility
Age20 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05365425