OXIDATIVE STRESS & CV DENERVATION IN DIABETES: AN INTERVENTIONAL TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Type I diabetes is a common condition affecting millions of individuals worldwide. Chronic and disabling complications are common with this disease, including a type of cardiovascular nerve damage (cardiovascular diabetic autonomic neuropathy (DAN)) that can occur in up to 50% of all people with diabetes. Cardiovascular DAN may cause changes in heart rhythms by altering electrical stability and/or impairing blood flow within the heart. The proposed studies will utilize nuclear medicine techniques to help determine if the progression of DAN can be slowed or even reversed by the administration of three investigational medications. Persons with type 1 diabetes and mild to moderate DAN will potentially be able to enroll in the study. The clinical trial is a double-blind, placebo controlled study consisting of two groups; Group 1 will receive three investigational medications (alpha-lipoic acid (Alipure), nicotinamide (Enduramide), and allopurinol (Zyloprim)); Group 2 will receive matched oral placebos for 24 months. Participants will be assigned randomly to one of these two groups. Primary efficacy variables will be determined using nuclear medicine imaging techniques; secondary variables will be determined by utilizing laboratory measures of systemic oxidative stress and acute phase reactants. Exploratory endpoints will be assessed with retinal photographs, measures of kidney function, measures of heart rate variability (HRV), and clinical assessments of neuropathy.