The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients
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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.
Condition or disease
Type 2 Diabetes MellitusPeripheral Microvascular Symptoms
Drug: Prostaglandin I2Drug: Placebo
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
45 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type II diabetes mellitus patient
Patients with symptoms of a minute peripheral blood flow disorder
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