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

NCT01796418 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2013-12-16

No results posted yet for this study

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.

Conditions

  • Diabetic Nephropathy

Interventions

DRUG

Beraprost sodium

Sponsors & Collaborators

  • Astellas Pharma Korea, Inc.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Chun-Soo Lim, Prof · Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea

  • Dong Ki Kim, Prof · Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea

  • Ki Young Na, Prof · Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

  • Sung Gyun Kim, Prof · Hallym University Medical Center

  • Young-Ki Lee, Prof · Hallym University Kangnam Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01796418 on ClinicalTrials.gov