RecruitingPhase 4NCT05365438

Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia

Sponsor

Seoul National University Bundang Hospital

Enrollment

105 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Atherosclerosis Dyslipidemias

Summary

This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.

Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria7

Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
Male or female of 20 years or over
Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL
moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg
Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
Creatinine ≤1.8 mg/dL

Exclusion Criteria7

Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
Uncontrolled hypertension: SBP \>180 mmHg or DBP \>110 mmHg
Severe renal dysfunction: eGFR \<30 mL/min/1.73m2
AST/ALT \>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
Usage of dyslipidemia therapy other than statin