Clinical trial NCT01796418: Beraprost Sodium and Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy
Official title: Effect of Beraprost Sodium on Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy (BESTinDN Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Nephropathy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2013-02-21
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Brachial ankle pulse wave velocity (PWV)
timeFrame: 12 weeks
Secondary outcomes:
measure: Ankle brachial indices (ABI)
timeFrame: 12 weeks
measure: Urine albumin creatinine ratio (UACR)
timeFrame: 12 weeks
measure: IDMS MDRD estimated glomerular filtration rate (eGFR)
timeFrame: 12 weeks
measure: Lipid profiles
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea
name: Chun-Soo Lim, Prof
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
name: Dong Ki Kim, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
name: Ki Young Na, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Medical Center
name: Sung Gyun Kim, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Young-Ki Lee, Prof
role: PRINCIPAL_INVESTIGATOR
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citation: Na KY, Kim DK, Kim SG, Lee YK, Lim CS. Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy. Trials. 2013 Sep 2;14:275. doi: 10.1186/1745-6215-14-275.