Beraprost Sodium and Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetic Nephropathy |
Drug: Beraprost sodium |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Beraprost Sodium on Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy (BESTinDN Study) |
- Brachial ankle pulse wave velocity (PWV) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The change of brachial ankle PWV at 12 weeks compared to baseline (0 week)
- Ankle brachial indices (ABI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The change of ABI at 12 weeks compared to baseline (0 week)
- Urine albumin creatinine ratio (UACR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The change of UACR at 12 weeks compared to baseline (0 week)
- IDMS MDRD estimated glomerular filtration rate (eGFR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The change of IDMS MDRD eGFR at 12 weeks compared to baseline (0 week)
- Lipid profiles [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The change of total cholesterol, LDL-cholesterol, and triglyceride at 12 weeks compared to baseline (0 week)
- Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The change of systolic and diastolic blood pressure at 12 weeks compared to baseline (0 week)
| Estimated Enrollment: | 102 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Beraprost sodium
Beraprost sodium 0.02 mg capsule by mouth every 12 hours for 12 weeks
|
Drug: Beraprost sodium
Other Name: Berasil
|
|
Placebo Comparator: Placebo
Placebo capsule by mouth every 12 hours for 12 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Chun-Soo Lim, Prof | 82-2-870-2120 | cslimjy@snu.ac.kr |
| Contact: Dong Ki Kim, Prof | 82-2-2072-2303 | dkkim73@gmail.com |
| Korea, Republic of | |
| Hallym University Sacred Heart Hospital | Not yet recruiting |
| Anyang, Korea, Republic of | |
| Contact: Sung Gyun Kim, Prof 82-31-380-3728 sgkim@hallym.ac.kr | |
| Principal Investigator: Sung Gyun Kim, Prof | |
| Seoul National University Bundang Hospital | Not yet recruiting |
| Seongnam, Korea, Republic of | |
| Contact: Ki Young Na, Prof kyna@snubh.org | |
| Principal Investigator: Ki Young Na, Prof | |
| Seoul National University Hospital | Not yet recruiting |
| Seoul, Korea, Republic of | |
| Contact: Dong Ki Kim, Prof 82-2-2072-2303 dkkim73@gmail.com | |
| Principal Investigator: Dong Ki Kim, Prof | |
| Seoul National University Boramae Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of | |
| Contact: Chun-Soo Lim, Prof 82-2-872-2120 cslimjy@snu.ac.kr | |
| Principal Investigator: Chun-Soo Lim, Prof | |
| Kangnam Sacred Heart Hospital | Not yet recruiting |
| Seoul, Korea, Republic of | |
| Contact: Young-Ki Lee, Prof 82-2-829-5114 km2071@naver.com | |
| Principal Investigator: Young-Ki Lee, Prof | |
| Study Chair: | Chun-Soo Lim, Prof | Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea |
| Principal Investigator: | Dong Ki Kim, Prof | Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea |
| Principal Investigator: | Ki Young Na, Prof | Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea |
| Principal Investigator: | Sung Gyun Kim, Prof | Hallym University Medical Center |
| Principal Investigator: | Young-Ki Lee, Prof | Kangnam Sacred Heart Hospital |
More Information
Publications:
| Responsible Party: | Dong Ki Kim, Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01796418 History of Changes |
| Other Study ID Numbers: | BESTinDN-001 |
| Study First Received: | February 19, 2013 |
| Last Updated: | February 19, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetic Nephropathies Kidney Diseases Urologic Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Beraprost Epoprostenol |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 16, 2013