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Completed

NCT Number: NCT01061060

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul, Seodaemun-gu, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostaglandin I2

Drug

oral

Other names: Beraprost Na

Placebo

Drug

oral

Primary outcomes

  1. Symptomatic improvement by Total Symptom Score (TSS)

    Time frame: after 8-week treatment

Secondary outcomes

  1. Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise

    Time frame: after 8-week treatment

  2. Change in mean rate of blood flow in the toes

    Time frame: after 8-week treatment

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 2, 2010
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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