Back to resultsThe Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients
Primary Purpose
Type 2 Diabetes Mellitus, Peripheral Microvascular Symptoms
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prostaglandin I2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Prostaglandin I2, Beraprost Na, Endothelial cell function
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Beraprost group
Placebo group
Arm Description
Prostaglandin I2
Outcomes
Primary Outcome Measures
Symptomatic improvement by Total Symptom Score (TSS)
Secondary Outcome Measures
Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise
Change in mean rate of blood flow in the toes
Full Information
NCT ID
NCT01061060
First Posted
February 1, 2010
Last Updated
February 11, 2016
Sponsor
Yonsei University
Collaborators
Astellas Pharma Korea, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01061060
Brief Title
The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
Collaborators
Astellas Pharma Korea, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Peripheral Microvascular Symptoms
Keywords
Prostaglandin I2, Beraprost Na, Endothelial cell function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beraprost group
Arm Type
Experimental
Arm Description
Prostaglandin I2
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Prostaglandin I2
Other Intervention Name(s)
Beraprost Na
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Symptomatic improvement by Total Symptom Score (TSS)
Time Frame
after 8-week treatment
Secondary Outcome Measure Information:
Title
Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise
Time Frame
after 8-week treatment
Title
Change in mean rate of blood flow in the toes
Time Frame
after 8-week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Dong-Hoon Choi
Organizational Affiliation
Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University
Official's Role
Principal Investigator
Facility Information:
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients
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