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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

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.

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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.

Conditions

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Type 2 Diabetes Mellitus Peripheral Microvascular Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Beraprost group

Prostaglandin I2

Group Type EXPERIMENTAL

Prostaglandin I2

Intervention Type DRUG

oral

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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Prostaglandin I2

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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Beraprost Na

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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No