Effect of Fimasartan or Amlodipine on Extended Renin-angiotensin System in Patients With Type 2 Diabetes and Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Angiotensin(1-7)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
研究组 & 干预措施
Amlodipine
- Comparator group: Amlodipine, 5 mg once a day, oral administration
干预措施: Fimasartan (Drug)
Fimasartan
- Fimasartan group: Fimasartan, 60 mg once a day, oral administration
干预措施: Fimasartan (Drug)
结局指标
主要结局
Angiotensin(1-7)
时间窗: 12 weeks
Changes of serum angiotensin(1-7) at week 12 from baseline
次要结局
- Renin(12 weeks)
- angiotensin(12 weeks)
- atherosclerosis(12 weeks)
- Muscle mass(12 weeks)
- HbA1c(12 weeks)
- Blood pressure(12 weeks)
- ACE-2(12 weeks)
- ACE(12 weeks)
- Fat mass(12 weeks)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital