Seoul, Seodaemun-gu, 120-752, South Korea
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
45 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
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
Drugoral
Other names: Beraprost Na
Placebo
Drugoral
Primary outcomes
-
Symptomatic improvement by Total Symptom Score (TSS)
Time frame: after 8-week treatment
Secondary outcomes
-
Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise
Time frame: after 8-week treatment
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Effect of Diabetic Medications on Bone Metabolism
NCT00467285
Bone Diseases, Bone Diseases, Metabolic
View Trial DetailsStudy of HTD4010 in Healthy Volunteers
NCT02538848
Diabetes Mellitus, Diabetes Mellitus, Type 2
Perth, Australia
View Trial DetailsEfficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
NCT06353347
Diabetes Mellitus, Diabetes Mellitus, Type 2
Baotou, China
View Trial DetailsPeer-Supported Diabetes Self-Care Intervention to Improve Health Related Quality of Life (HRQoL) and Diabetes Management
NCT05637437
Diabetes Mellitus, Diabetes Mellitus, Type 2
Serdang, Selangor, Malaysia
View Trial Details