The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01061060
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : February 15, 2016
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Donghoon Choi, Yonsei University

Brief Summary:
This study attempts to examine the effect of oral prostaglandin I2 (Beraprost Na), administered for eight weeks, on the endothelial cell functional disorder among asymptomatic high risk diabetes mellitus patients.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Peripheral Microvascular Symptoms Drug: Prostaglandin I2 Drug: Placebo Phase 4

Detailed Description:
This study plans to include those subjects who have complaint of peripheral microvascular symptoms but have evidences of having neither a coronary arterial disease nor a peripheral arterial disease and show normal findings in the vascular stiffness test (PWV and ABI)) and plethysmography of the legs (PVR)) ,among Type II diabetes mellitus patients of forty-five (45) years old or older, This study is conducted by using a randomized double blind method. These drugs are distributed through a pharmacy in the clinical study center and administered randomly for eight weeks while this study allots patients by using a double blind method. Beraprost Na is administered along with a placebo that was manufactured by the same manufacturer to have the identical exterior look and weight of Beraprost Na. After eight weeks of drug administration, this investigation attempts to verify symptomatic improvement and change in the endothelial function by using VENDYS® and ICG perfusion imaging.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Prostaglandin I2 (Beraprost Na), Administered Orally for Eight Weeks, on the Endothelial Cell Functional Disorder in Type II Diabetes Mellitus Patients With Symptoms of a Minute Peripheral Blood Flow Disorder
Study Start Date : January 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Beraprost group
Prostaglandin I2
Drug: Prostaglandin I2
Other Name: Beraprost Na
Placebo Comparator: Placebo group Drug: Placebo

Primary Outcome Measures :
  1. Symptomatic improvement by Total Symptom Score (TSS) [ Time Frame: after 8-week treatment ]

Secondary Outcome Measures :
  1. Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise [ Time Frame: after 8-week treatment ]
  2. Change in mean rate of blood flow in the toes [ Time Frame: after 8-week treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type II diabetes mellitus patient
  • Patients with symptoms of a minute peripheral blood flow disorder

Exclusion Criteria:

  • Cases with either an already-diagnosed coronary arterial disease or a peripheral vascular disease
  • Cases with a history of stroke
  • Cases with an abnormal finding of vascular stiffness test (PWV and ABI) and plethysmography of legs (PVR)
  • Pregnant women or fertile women with an unclear pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01061060

Korea, Republic of
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Astellas Pharma Korea, Inc.
Principal Investigator: Professor Dong-Hoon Choi Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University

Responsible Party: Donghoon Choi, professor, Yonsei University Identifier: NCT01061060     History of Changes
Other Study ID Numbers: BER-CL-AKR-2009-01
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016

Keywords provided by Donghoon Choi, Yonsei University:
Prostaglandin I2
Beraprost Na
Endothelial cell function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents
Antihypertensive Agents