Clinical trial NCT01061060: The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Peripheral Microvascular Symptoms
Keywords: Prostaglandin I2
Beraprost Na
Endothelial cell function
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2010-02-02
Enrollment: 110
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic improvement by Total Symptom Score (TSS)
timeFrame: after 8-week treatment
Secondary outcomes:
measure: Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise
timeFrame: after 8-week treatment
measure: Change in mean rate of blood flow in the toes
timeFrame: after 8-week treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
state: Seodaemun-gu
Study officials:
affiliation: Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University
name: Professor Dong-Hoon Choi
role: PRINCIPAL_INVESTIGATOR
References: