Beraprost Sodium & Arterial Stiffness in Patients With Type 2 Diabetic

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01796418
Study type	Interventional
Source	Seoul National University Hospital
Contact	Chun-Soo Lim, Prof
Phone	82-2-870-2120
Email	cslimjy@snu.ac.kr
Status	Recruiting
Phase	N/A
Start date	March 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04562025` - Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy	N/A
Not yet recruiting	`NCT03658317` - Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy	N/A
Recruiting	`NCT02501772` - The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy	N/A
Completed	`NCT02829177` - Microalbuminuria and Allopurinol in Type 1 Diabetes	Phase 4
Completed	`NCT02251067` - Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients	Phase 2
Completed	`NCT02276196` - Effect of LIXIsenatide on the Renal System	Phase 4
Completed	`NCT01440257` - A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria	Phase 2
Active, not recruiting	`NCT01273675` - An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy	N/A
Terminated	`NCT01129557` - Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease	Phase 4
Completed	`NCT00317954` - Spironolactone in Diabetic Nephropathy	Phase 4
Active, not recruiting	`NCT02237352` - Mechanisms of Diabetic Nephropathy in Ecuador
Not yet recruiting	`NCT05061459` - The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy
Completed	`NCT01935167` - To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy	Phase 2
Recruiting	`NCT01673204` - Clinical Trial Technology Development for the Validation of Surrogate Prognostic Markers in Patients With Diabetic Nephropathy	Phase 4
Completed	`NCT01726816` - Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy	Phase 2
Recruiting	`NCT01458158` - Matrix Metalloproteinases in Atherosclerosis of Chronic Kidney Disease	N/A
Completed	`NCT01476501` - Vitamin D Supplementation in Diabetic Nephropathy	Phase 2
Completed	`NCT01447147` - A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy	Phase 2
Completed	`NCT01003236` - Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy	Phase 2
Completed	`NCT00535925` - Nephropathy In Type 2 Diabetes and Cardio-renal Events	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms