Atherosclerosis, Diabetes Mellitus, Type 2, Dyslipidemias
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGOmega 3-Atorvastatin
Atmeg 2 capsules with 1 pack of Omethyl cutielet
ezetimibe/atorvastatin 10/20 mg
Sponsors
Seoul National University Bundang Hospital
Korea United Pharm. Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
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 under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL * moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg * Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm * Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction * Creatinine ≤1.8 mg/dL
Exclusion criteria
* Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL * Uncontrolled hypertension: SBP \>180 mmHg or DBP \>110 mmHg * Severe renal dysfunction: eGFR \<30 mL/min/1.73m2 * AST/ALT \>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 * Usage of dyslipidemia therapy other than statin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid intima media thickness | 24 weeks | maximum carotid IMT (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area of carotid artery plaque | 24 weeks | measured by ultrasound |
| Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics | 24 weeks | changes of non-calcified plaque volume (mm3) |
| Glucose homeostasis | 24 weeks | changes of HbA1c (%) |
| Lipid metabolism | 24 weeks | TG concentration, HDL-cholesterol concentration |
| Bioelectrical Impedance Analysis | 24 weeks | Body composition of fat mass (kg) |
| Proteinuria | 24 weeks | albumin-to-creatinine ratio (mg/g) |
| Changes of gut microbiota | 24 weeks | 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