S-Space College of Medicine/School of Medicine (의과대학/대학원) Internal Medicine (내과학전공) Journal Papers (저널논문_내과학전공)
Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy
- Na, Ki Young; Kim, Dong Ki; Kim, Sung Gyun; Lee, Young-Ki; Lim, Chun Soo
- Issue Date
- BioMed Central Ltd.
- Trials Vol.14 No.275, pp. 1-6
- Beraprost sodium; Arterial stiffness; Diabetic nephropathy; Cardiovascular; Pulse wave velocity
- Trial registration : ClinicalTrials.gov number NCT01796418
- Background : Diabetic nephropathy is the leading cause of end-stage renal disease (ESRD). Cardiovascular (CV) complications are the most common cause of death among ESRD patients. Beraprost sodium (BPS) is a prostacyclin analog with vasodilatory and antiplatelet effects.
Methods : This is a multicenter prospective, randomized, double-blind, placebo-controlled trial to determine whether treatment with BPS improves arterial stiffness in patients with type 2 diabetic nephropathy. A total of 102 participants with type 2 diabetic nephropathy will be screened, enrolled, and randomly assigned to receive either 80 μg BPS or placebo daily for 12 weeks. The primary outcome is the change in brachial-ankle pulse wave velocity between baseline and after 12 weeks of medication use. The secondary outcomes will include changes in the ankle-brachial index, the urine albumin to creatinine ratio, the estimated glomerular filtration rate, lipid profiles, and blood pressure from baseline to after treatment.
Discussion : This clinical trial is the first to investigate the effects of BPS on changes in CV biomarkers, albuminuria, renal function, and lipid profiles in patients with diabetic nephropathy.