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

NCT01061060 — Phase 4, Completed, 110 participants, Yonsei University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01061060
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	110 (Actual)
Sponsor	Yonsei University (Other); collaborators: Astellas Pharma Korea, Inc.
Conditions	Type 2 Diabetes Mellitus, Peripheral Microvascular Symptoms
Interventions	Prostaglandin I2, Placebo (Drug)
Dates	start 2010-01-01, primary completion 2010-10-01, completion 2010-10-01, first posted 2010-02-02, last updated 2016-02-15
Locations	1 site in South Korea

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Beraprost group	Experimental	Drug: Prostaglandin I2	Prostaglandin I2
Placebo group	Placebo comparator	Drug: Placebo

Prostaglandin I2 (Drug), also known as Beraprost Na: oral
Placebo (Drug): oral

+Outcome measures

Primary outcomes

Symptomatic improvement by Total Symptom Score (TSS) [after 8-week treatment]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 45 Years to any

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

+Locations (1)

Facility	City	Country	Status
	Seoul, Seodaemun-gu	South Korea

+Investigators

Professor Dong-Hoon Choi, Principal investigator, Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University