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. The Diabetes Control and Complications Trial (DCCT) was a multicenter, randomized clinical trial designed to compare intensive with conventional diabetes therapy with regard to their effects on the development and progression of the early vascular and neurologic complications of insulin-dependent diabetes mellitus. A total of 1441 patients with IDDM - 726 with no retinopathy at baseline (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) -- were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly. Intensive therapy was found to effectively delay the onset and slow the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM. The Epidemiology of Diabetes Intervention and Complications (EDIC) is an epidemiologic investigation, especially for the study of macrovascular disease in IDDM, in the population in the DCCT. Among the major study goals are the following: 1. To determine the long-term course, including development and progression, of atherosclerotic cardiovascular (coronary, peripheral and cerebral) disease in IDDM. 2. To study the long-term evolution of microalbuminuria and clinical nephropathy in a carefully characterized population of persons with IDDM studied from early in their clinical course. 3. To study the rate of development of clinically significant neuropathy and its relationship to other complications. 4. To examine the development of advanced retinopathy in a well characterized cohort of IDDM patients. 5. To examine the long-term effects ('imprinting') of diabetes treatment (conventional vs. intensive) during the DCCT on the subsequent development and progression microvascular complications 6. To explore further and analyze the association between glycemic levels over time and the development and progression of long-term diabetic complications. Currently, there are 357 active probands, and 47 inactive probands. The characteristics of the currently active study population include an average age of 44; 52% male predominance; average diabetes duration of 22 years. Despite the equalization of glycemic control in the two treatment groups since 1993, there has been a sustained effect of prior intensive therapy on the progression of both retinopathy and nephropathy. We have not reported the required 50 subjects in the conventional group with cardiovascular events in order to perform statistical analysis. However, we have been able to demonstrate a positive impact of intensive therapy on the progression of atherosclerosis, as measured by the progression of carotid artery intima-media thickness.
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