Atherosclerosis, Diabetes Mellitus, Type 2, Dyslipidemia
Conditions
Brief summary
This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
Detailed description
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.
Interventions
choline fenofibrate 178.8mg (135mg as fenofibric acid)
DRUGPolicosanol
policosanol 10mg
Sponsors
Seoul National University Bundang Hospital
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit * Male or female of 20 years or over * Mixed dyslipidemia: triglyceride 200\~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL * Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm * Creatinine ≤1.8 mg/dL
Exclusion criteria
* Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL * Uncontrolled hypertension * Severe renal dysfunction * GOT/GPT \>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 * Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid intima media thickness | 24 week | Maximum carotid IMT (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area of carotid artery plaque | 24 week | measured by ultrasound |
| Plaque characteristics | 24 week | changes of non-calcified plaque volume (mm3) |
| Glucose homeostasis | 24 week | changes of HbA1c (%) |
| Lipid metabolism | 24 week | TG concentration, HDL-cholesterol concentration |
| Bioelectrical Impedance Analysis | 24 week | Body composition of fat mass (kg) |
| Proteinuria | 24 week | albumin-to-creatinine ratio (mg/g) |
| changes of gut microbiota | 24 week | measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species |
Countries
South Korea
Contacts
CONTACTSoo Lim
CONTACTMinji Sohn
Outcome results
None listed