Beraprost Sodium and Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy

Seoul National University

Status

Unknown

Conditions

Diabetic Nephropathy

Treatments

Drug: Beraprost sodium

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01796418

BESTinDN-001

Details and patient eligibility

About

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.

Enrollment

102 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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