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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Peripheral Microvascular Symptoms

Intervention / Treatment
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* Drug: Prostaglandin I2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beraprost group<br>Prostaglandin I2 | Drug: Prostaglandin I2<br>* oral<br>* Other names: Beraprost Na;|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic improvement by Total Symptom Score (TSS) |  | after 8-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise |  | after 8-week treatment | 
| Change in mean rate of blood flow in the toes |  | after 8-week treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostaglandin I2, Beraprost Na, Endothelial cell function