Type 2 Diabetes Mellitus Clinical Trial
Official title:
Signaling Mechanisms and Vascular Function in Diabetes Mellitus
Ruboxistaurin is being tested to see if it is effective in treating certain diabetic complications, such as diseases of the blood vessels.
To test the hypothesis that activation of protein kinase C impairs vascular reactivity in
patients with diabetes.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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