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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061060
• Other study ID #: BER-CL-AKR-2009-01
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2010
• Last updated: February 11, 2016
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: February 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Peripheral Microvascular Symptoms
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Prostaglandin I2
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic improvement by Total Symptom Score (TSS)		after 8-week treatment	No
Secondary	Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise		after 8-week treatment	No
Secondary	Change in mean rate of blood flow in the toes		after 8-week treatment	No