Diabetes Mellitus, Type 2 Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 105 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | SNUBH | Seongnam | Gyeonggi |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Bundang Hospital | Korea United Pharm. Inc. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Carotid intima media thickness | maximum carotid IMT (mm) | 24 weeks | |
| Secondary | Area of carotid artery plaque | measured by ultrasound | 24 weeks | |
| Secondary | Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics | changes of non-calcified plaque volume (mm3) | 24 weeks | |
| Secondary | Glucose homeostasis | changes of HbA1c (%) | 24 weeks | |
| Secondary | Lipid metabolism | TG concentration, HDL-cholesterol concentration | 24 weeks | |
| Secondary | Bioelectrical Impedance Analysis | Body composition of fat mass (kg) | 24 weeks | |
| Secondary | Proteinuria | albumin-to-creatinine ratio (mg/g) | 24 weeks | |
| Secondary | Changes of gut microbiota | measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species | 24 weeks |
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|---|---|---|---|
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