RecruitingPhase 4NCT05365425

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

Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia


Sponsor

Seoul National University Bundang Hospital

Enrollment

56 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether choline fenofibrate (a cholesterol and triglyceride medication) can slow the buildup of plaque in the carotid arteries in people with type 2 diabetes who have abnormal cholesterol levels. **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: elevated triglycerides (200–499 mg/dL) and low HDL cholesterol - You have a confirmed carotid artery plaque on imaging (intima-media thickness of 1.0 mm or more) - Your kidney function is adequate (creatinine 1.8 mg/dL or less) **You may NOT be eligible if...** - Your triglycerides are 500 mg/dL or higher, or your LDL cholesterol is 190 mg/dL or higher (requiring different therapy) - You have uncontrolled high blood pressure - You have severe kidney or liver disease - You are pregnant or a woman of childbearing potential not using contraception 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

DRUGCholine fenofibrate

choline fenofibrate 178.8mg (135mg as fenofibric acid)

DRUGPolicosanol

policosanol 10mg


Locations(1)

SNUBH

Seongnam-si, Gyeonggi-do, South Korea

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NCT05365425


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