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.
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
Atmeg 2 capsules with 1 pack of Omethyl cutielet
Atmeg 2 capsules
ezetimibe/atorvastatin 10/20 mg
SNUBH
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGCarotid intima media thickness
maximum carotid IMT (mm)
Time frame: 24 weeks
Area of carotid artery plaque
measured by ultrasound
Time frame: 24 weeks
Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics
changes of non-calcified plaque volume (mm3)
Time frame: 24 weeks
Glucose homeostasis
changes of HbA1c (%)
Time frame: 24 weeks
Lipid metabolism
TG concentration, HDL-cholesterol concentration
Time frame: 24 weeks
Bioelectrical Impedance Analysis
Body composition of fat mass (kg)
Time frame: 24 weeks
Proteinuria
albumin-to-creatinine ratio (mg/g)
Time frame: 24 weeks
Changes of gut microbiota
measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species
Time frame: 24 weeks
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