Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Choline Fenofibrate 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 choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
| Status | Recruiting |
| Enrollment | 56 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| 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: 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) |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | SNUBH | Seongnam | Gyeonggi |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Bundang Hospital | Daewon Pharmaceutical Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Carotid intima media thickness | Maximum carotid IMT (mm) | 24 week | |
| Secondary | Area of carotid artery plaque | measured by ultrasound | 24 week | |
| Secondary | Plaque characteristics | changes of non-calcified plaque volume (mm3) | 24 week | |
| Secondary | Glucose homeostasis | changes of HbA1c (%) | 24 week | |
| Secondary | Lipid metabolism | TG concentration, HDL-cholesterol concentration | 24 week | |
| Secondary | Bioelectrical Impedance Analysis | Body composition of fat mass (kg) | 24 week | |
| Secondary | Proteinuria | albumin-to-creatinine ratio (mg/g) | 24 week | |
| Secondary | changes of gut microbiota | measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species | 24 week |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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