Clinical trial NCT05365438: Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Official title: Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dyslipidemias
Atherosclerosis
Diabetes Mellitus, Type 2
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Korea United Pharm. Inc.
First posted: 2022-05-09
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Carotid intima media thickness
timeFrame: 24 weeks
Secondary outcomes:
measure: Area of carotid artery plaque
timeFrame: 24 weeks
measure: Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics
timeFrame: 24 weeks
measure: Glucose homeostasis
timeFrame: 24 weeks
measure: Lipid metabolism
timeFrame: 24 weeks
measure: Bioelectrical Impedance Analysis
timeFrame: 24 weeks
measure: Proteinuria
timeFrame: 24 weeks
measure: Changes of gut microbiota
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: SNUBH
state: Gyeonggi
Study officials:
References: