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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

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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