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临床试验/NCT01796418
NCT01796418Unknown不适用

Effect of Beraprost Sodium on Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy (BESTinDN Study)

Seoul National University Hospital5 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
102
试验地点
5
主要终点
Brachial ankle pulse wave velocity (PWV)

研究概览

简要总结

Diabetic nephropathy, the leading cause of end-stage renal disease in many countries, is characterized by high cardiovascular mortality and morbidity even in the early course of the disease. In addition, cardiovascular complication has been the most common cause of death in these patients. Thus, early detection and appropriate intervention for this highly common and critical complication is considered to play an important role in the management of the disease. In this regard, much interest has been focused on the early markers which can predict arterial diseases before the clinically apparent cardiovascular diseases. Recently, glowing evidence suggests that arterial stiffness as assessed by pulse wave velocity (PWV) may serve as a surrogate marker for future cardiovascular disease. In fact, increased PWV has been known to be independently associated with diabetic nephropathy in type 2 diabetes.

Beraprost sodium (BPS) is a stable orally active prostacyclin (PGI2) analogue that has a potent vasodilatory and anti-platelet effect. Also, BPS has been suggested to improve a micro-vascular circulation through a reduction of red blood cell deformability. In addition, recent studies have demonstrated that BPS improves endothelial function through an increase in endothelial nitric oxide synthesis and NO synthase gene transcription. These beneficial effects of BPS have been known to reduce PWV in patients prone to cardiovascular diseases such as elderly, hypertension, or a history of cerebral infarction. However, the effect of BPS on arterial stiffness in patients with diabetic nephropathy remains elusive. Our study will address the effect of BPS on arterial stiffness by PWV in patients with diabetic nephropathy.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 19 years or more and 75 years or less
  • Type 2 diabetes who is prescribed glucose-lowering agent or insulin
  • Estimated glomerular filtration rate (GFR) by isotope dilution mass spectrometry (IDMS)- Modification of Diet in Renal Disease (MDRD) equation 30 ml/min/1.73 m2 or more
  • verified 2 times or more of albuminuria 30 mg/g cr (or protein 300 mg/g cr)or more in a spot urine sample with interval of 1 week or more in recent 6 months
  • Patients whose blood pressure is 140/90 mmHg or less and did not receive a prescription for additional antihypertensive medication in recent 3 months
  • Patients who give written consent to this study by oneself

排除标准

  • History of kidney transplantation
  • current advanced congestive heart failure (NYHA class III or more)
  • current uncontrolled arrhythmia
  • current advanced liver cirrhosis (Child-Pugh class C)
  • History of bleeding diathesis
  • current active infection or uncontrolled inflammatory disorders
  • History of cerebrovascular accident or myocardial infarction
  • current use of anticoagulant
  • current use of two or more antiplatelet agents
  • patients with advanced malignancy (life expectancy less than 6 months)
  • patients with uncontrolled diabetes (Hba1c more than 10%)
  • patients with severe anemia (Hb less than 8.0 g/dL)
  • female who are pregnant, trying to get pregnant or lactating
  • Genetic diseases such as galactose intolerance, lactose deficiency or glucose-galactose malabsorption

研究组 & 干预措施

Beraprost sodium

Experimental

Beraprost sodium 0.02 mg capsule by mouth every 12 hours for 12 weeks

干预措施: Beraprost sodium (Drug)

结局指标

主要结局

Brachial ankle pulse wave velocity (PWV)

时间窗: 12 weeks

The change of brachial ankle PWV at 12 weeks compared to baseline (0 week)

次要结局

  • Ankle brachial indices (ABI)(12 weeks)
  • Urine albumin creatinine ratio (UACR)(12 weeks)
  • IDMS MDRD estimated glomerular filtration rate (eGFR)(12 weeks)
  • Lipid profiles(12 weeks)
  • Blood pressure(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Ki Kim

Professor

Seoul National University Hospital

研究点 (5)

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