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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination pill of atorvastatin (a statin) and omega-3 fatty acids can slow carotid artery plaque buildup in people with type 2 diabetes who have mixed cholesterol abnormalities and are already on a moderate-intensity statin. **You may be eligible if...** - You are 20 or older with type 2 diabetes on treatment (HbA1c between 6.0–10.0%) - You have mixed dyslipidemia despite already being on a moderate-intensity statin: triglycerides at or above 200 mg/dL, low HDL, and LDL above 100 mg/dL - You have confirmed carotid artery plaque on imaging (intima-media thickness of 1.0 mm or more) - You are asymptomatic with no history of heart attack, stroke, or coronary artery procedures **You may NOT be eligible if...** - You have had a prior heart attack, stroke, or chest pain episodes - You have significant kidney or liver disease - You are pregnant or a woman of childbearing potential not using contraception - You have a known allergy to statins or omega-3 medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOmega 3-Atorvastatin

Atmeg 2 capsules with 1 pack of Omethyl cutielet

DRUGOmega 3-Atorvastatin

Atmeg 2 capsules

DRUGAtorvastatin-Ezetimibe

ezetimibe/atorvastatin 10/20 mg


Locations(1)

SNUBH

Seongnam-si, Gyeonggi-do, South Korea

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NCT05365438


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