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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01061060

Enrollment

110

Registered

2010-02-02

Start date

2010-01-31

Completion date

2010-10-31

Last updated

2016-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Microvascular Symptoms, Type 2 Diabetes Mellitus

Keywords

Prostaglandin I2, Beraprost Na, Endothelial cell function

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.

Interventions

DRUGProstaglandin I2

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Symptomatic improvement by Total Symptom Score (TSS)	after 8-week treatment

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026