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| Name | Class |
|---|---|
| Astellas Pharma Korea, Inc. | INDUSTRY |
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This study attempts to examine the effect of oral prostaglandin I2 (Beraprost Na), administered for eight weeks, on the endothelial cell functional disorder among asymptomatic high risk diabetes mellitus patients.
This study plans to include those subjects who have complaint of peripheral microvascular symptoms but have evidences of having neither a coronary arterial disease nor a peripheral arterial disease and show normal findings in the vascular stiffness test (PWV and ABI)) and plethysmography of the legs (PVR)) ,among Type II diabetes mellitus patients of forty-five (45) years old or older, This study is conducted by using a randomized double blind method. These drugs are distributed through a pharmacy in the clinical study center and administered randomly for eight weeks while this study allots patients by using a double blind method. Beraprost Na is administered along with a placebo that was manufactured by the same manufacturer to have the identical exterior look and weight of Beraprost Na. After eight weeks of drug administration, this investigation attempts to verify symptomatic improvement and change in the endothelial function by using VENDYS® and ICG perfusion imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beraprost group | Experimental | Prostaglandin I2 |
|
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostaglandin I2 | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic improvement by Total Symptom Score (TSS) | after 8-week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise | after 8-week treatment | |
| Change in mean rate of blood flow in the toes | after 8-week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor Dong-Hoon Choi | Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | Seodaemun-gu | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011464 | Epoprostenol |
| ID | Term |
|---|---|
| D044062 | Prostaglandins I |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Placebo | Drug | oral |
|
| D004700 | Endocrine System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |