A Phase 4 interventional study of Prostaglandin I2 and Placebo in Type 2 Diabetes Mellitus and Peripheral Microvascular Symptoms, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2016-02-15.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 110 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
Prostaglandin I2
Drug: Prostaglandin I2
Drug: Placebo
oral
Also known as: Beraprost Na
oral
Symptomatic improvement by Total Symptom Score (TSS)
Time frame: after 8-week treatment
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
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Yonsei University