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In this study, we will assess the change of extended renin-angiotensin system including serum ACE-2 and angiotensin(1-7) levels and subclinical atherosclerosis after using fimasartan (an ARB), compared to amlodipine in hypertensive patients with T2DM.
Several clinical trials aimed at studying the benefits of RAS blockade in the diabetic complications. HOPE, RENAAL, IRMA2, IDNT, ONTARGET studies proved that ACE inhibitors or ARBs reduced the risk of diabetic complications.
Recent studies proved that fimasartan, one of the ARBs, stabilizes the activity of renin-angiotensin system. However, understanding the change in concentration of serum ACE, ACE-2, angiotensin(1-7), and angiotensin-II should help clinicians select more appropriate drug between ACE inhibitors and ARBs with clear evidence. Moreover, since RAS antagonists are the first-line drugs for antihypertensive therapy in patients with T2DM, it is meaningful to understand the change of RAS-related factors in serum after using the drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan | Experimental | - Fimasartan group: Fimasartan, 60 mg once a day, oral administration |
|
| Amlodipine | Active Comparator | - Comparator group: Amlodipine, 5 mg once a day, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug | - Fimasartan group: fimasartan, 60 mg once a day, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiotensin(1-7) | Changes of serum angiotensin(1-7) at week 12 from baseline | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Change in blood pressure from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 | 12 weeks |
| ACE-2 | Change in ACE-2 from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Lim, MD, PhD | Contact | 01097662706 | limsoo@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050197 | Atherosclerosis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
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| 12 weeks |
| ACE | Change in ACE from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 | 12 weeks |
| Renin | Change in renin from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 | 12 weeks |
| angiotensin | Change in angiotensin from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 | 12 weeks |
| atherosclerosis | Change in atherosclerosis from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 | 12 weeks |
| Muscle mass | Change in muscle mass from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 | 12 weeks |
| Fat mass | Change in fat mass from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 | 12 weeks |
| HbA1c | Change in HbA1c from baseline to week 12 Change in blood pressure from baseline to week 24 Change in blood pressure from baseline to week 24 | 12 weeks |
| D003920 |
| Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |