Atherosclerosis, Diabetes Mellitus, Type 2, Hypertension, Renin Hypertension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFimasartan
\- Fimasartan group: fimasartan, 60 mg once a day, oral administration
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 30 years old * Type 2 diabetes by American Diabetes Association criteria * HbA1c: 6.5% ≤ - \< 10.0% * Systolic blood pressure: 140 ≤ - \< 180 mmHg or Diastolic blood pressure: 85 ≤ - \< 110 mmHg * Statin (-) or no change in low to moderate intensity statin \[14\] dose in recent 3 months
Exclusion criteria
* Contraindication of fimasartan or amlodipine * History of RAS inhibitors (ACE inhibitors or ARBs) or calcium channel blockers in the previous 3 months * Pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women * Type 1 diabetes or diabetes secondary to chronic pancreatitis or to pancreatectomy * Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening * Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal) * Chronic kidney disease (serum creatinine \> 2.0 mg/dL) * Hyperkalemia serum potassium \>5.0 mEq/L * Any previous cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiotensin(1-7) | 12 weeks | Changes of serum angiotensin(1-7) at week 12 from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 12 weeks | 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 |
| ACE-2 | 12 weeks | 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 |
| Renin | 12 weeks | 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 |
| angiotensin | 12 weeks | 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 |
| ACE | 12 weeks | 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 |
| Muscle mass | 12 weeks | 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 |
| Fat mass | 12 weeks | 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 |
| HbA1c | 12 weeks | 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 |
| atherosclerosis | 12 weeks | 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 |
Countries
South Korea
Contacts
Primary ContactSoo Lim, MD, PhD
Outcome results
None listed