A Phase 2/3 interventional study of Ebselen and Placebo in Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-09-30.
Sponsored by Brigham and Women's Hospital · Phase 2/3, Interventional, and Basic science
The purpose of the study is to learn how blood vessel function is altered by diabetes. We are studying an investigational drug, Ebselen, to see if it can improve the ability of blood vessels to relax (widen).
A major cause of death and disability in patients with diabetes mellitus is atherosclerosis. Endothelial dysfunction is an important, if not primary, factor in atherogenesis. Nitric oxide is an important substance made and released by the endothelium. Many prior studies in animals and humans have shown that the ability of the blood vessel to dilate is impaired in diabetes. This process of vasodilation is mediated by a substance, nitric oxide, which is thought to be highly susceptible to destruction by oxidant molecules. In previous studies, we found that acute administration of the antioxidant, vitamin C, improves endothelium-dependent vasodilation in blood vessels of patients with type 1 and type 2 diabetes. This suggests that by scavenging oxidants, such as superoxide, vitamin C may reduce the destruction of nitric oxide and thereby preserve endothelial function. Additional mechanisms, including activation of a substance called protein kinase C, and oxidant stress from excess soluble peroxides may be present in diabetes and interact with oxidant stress to cause endothelial dysfunction in patients with diabetes. Accordingly, we would like to study both of these mechanisms to determine their contribution to endothelial dysfunction.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
history of clinically significant coronary artery or cerebrovascular disease (defined as MI or stroke within 6 months, or presence of unstable angina)
Placebo
Drug: Placebo
Ebselen
Drug: Ebselen
150 mg BID for 2 weeks
Placebo 1 po BID for 2 weeks
Endothelium-dependent and endothelium-independent vasodilation of peripheral resistance and conduit vessels will be studied in diabetic (type 1 and 2) and healthy subjects two weeks following randomization to the ebselen or placebo.
Time frame: one testing visit every 4 weeks
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ebselen
Brigham and Women's Hospital →