This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate 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
56
choline fenofibrate 178.8mg (135mg as fenofibric acid)
policosanol 10mg
SNUBH
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGCarotid intima media thickness
Maximum carotid IMT (mm)
Time frame: 24 week
Area of carotid artery plaque
measured by ultrasound
Time frame: 24 week
Plaque characteristics
changes of non-calcified plaque volume (mm3)
Time frame: 24 week
Glucose homeostasis
changes of HbA1c (%)
Time frame: 24 week
Lipid metabolism
TG concentration, HDL-cholesterol concentration
Time frame: 24 week
Bioelectrical Impedance Analysis
Body composition of fat mass (kg)
Time frame: 24 week
Proteinuria
albumin-to-creatinine ratio (mg/g)
Time frame: 24 week
changes of gut microbiota
measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species
Time frame: 24 week
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