Vision A significant need exists for improved diagnostics to predict, characterize and monitor Type 2 Diabetes Mellitus (T2DM). This need has become acute with the escalating occurrence of diabetes, the demonstrated value of early and accurate detection, and the accelerating rate of new candidate therapies entering clinical trials. Our vision is to create a highly integrated. multidisciplinary team specifically assembled to address this need by collectively advancing the discovery. validation and translation of novel biomarkers for diabetes (and its complications) into improved commercial diagnostics. Envisioned biomarkers may predict the onset of disease and define the optimal therapeutic or pharmaceutical interventions to Significantly improve patient outcomes. This unique team is being assembled to address and overcome the critical translational issues and accelerate development times by leveraging perspectives from clinical research, protein biomarker analysis, bioinformatics, product development, diagnostics commercialization, and new drug commercialization throughout the research process. Background and Significance It is estimated that Type 2 Diabetes Mellitus afflicts approximately 23 million Americans, with nearly one third of these individuals unaware that they are affected by the disease. Complications of diabetes are conservatively estimated to be the sixth leading cause of death in the U.S., and are found to occur disproportionately in minority populations. The prevalence of diabetes increased by - 50% over the decade from 1990 to 2000, is estimated to double in the next forty years. It is considered a pandemic threat within the nation with regard to increased mortality, decreased quality of life and escalating healthcare costs. In 2007, the estimated total national cost of diabetes was $174 billion, with a majority of that amount spent solely on medical expenditures (1). In addition to being a significant contributing factor to atherosclerosis and other adverse cardiovascular disease (CVD) outcomes (2, 3), diabetes results in 12,000 - 24,000 new cases of blindness each year, is responsible for -150,000 patients with end-stage kidney disease and accounts for 60% of non-traumatic lower limb amputations - 82,000 in 2002. (4). With regard to these major outcomes - death or disability - the effects of T2DM can be prevented (or at least delayed) through early detection and managed treatment. Non-drug treatment regimens focus on lifestyle intervention in the form of diet modification, weight loss and exercise programs (5-10). Classical drug treatment of aggressive T2DM is through sulfonylureas or metformin (11, 12), as well as formulations of short- and long-acting forms of insulin (13, 14). More recently, new drugs, as typified by dipeptidyl peptidase IV inhibitors (e.g., Januvia and Galvus) have shown great promise in controlling blood glucose levels (15). It has also been noted that undesired or unanticipated side-effects may accompany drug therapies as evidenced by the recent report that use of a thiazolidinedione (rosiglitazone) was associated with increased cardiovascular events (16). There are currently in excess of 350 drug candidates in development (e.g., GLP-1 analogs, DPP-IV inhibitors and SGL T2 inhibitors), making diabetes second only to cancer in health-related R&D focus (17). Important to both early detection and the effective administration of treatment is the need to monitor individuals across the spectrum of pre-diabetic to advanced disease, and to anticipate early indicators of adverse outcomes. For over two decades, blood glucose, hemoglobin HbA1c and urine microalbumin have been used almost exclusively as the biomarkers for detecting and monitoring the progression of the disease. It has become clear that these markers are insufficient when compared to the enormous scope of the disease, its complications, the number of new drug targets being examined and the n
|Effective start/end date||7/1/09 → 6/30/11|
- HHS: National Institutes of Health (NIH): $466,729.00
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