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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Peripheral Microvascular Symptoms; Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Prostaglandin I2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01061060

BER-CL-AKR-2009-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Beraprost group

Experimental group

Description:

Prostaglandin I2

Treatment:

Drug: Prostaglandin I2

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo