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| Name | Class |
|---|---|
| Daewon Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tgfenon | Experimental | Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet |
|
| Policosanol 10 | Active Comparator | Policosanol 10mg 1 tablet once daily oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline fenofibrate | Drug | choline fenofibrate 178.8mg (135mg as fenofibric acid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carotid intima media thickness | Maximum carotid IMT (mm) | 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| Area of carotid artery plaque | measured by ultrasound | 24 week |
| Plaque characteristics | changes of non-calcified plaque volume (mm3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Lim | Contact | +82-31-787-7035 | limsoo@snu.ac.kr | |
| Minji Sohn | Contact | rainbowmjs@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNUBH | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D050197 | Atherosclerosis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| C080710 | policosanol |
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| Policosanol | Drug | policosanol 10mg |
|
|
| 24 week |
| Glucose homeostasis | changes of HbA1c (%) | 24 week |
| Lipid metabolism | TG concentration, HDL-cholesterol concentration | 24 week |
| Bioelectrical Impedance Analysis | Body composition of fat mass (kg) | 24 week |
| Proteinuria | albumin-to-creatinine ratio (mg/g) | 24 week |
| changes of gut microbiota | measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species | 24 week |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |