This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Obesity and type 2 diabetes are occurring at epidemic rates. Studies suggest that these conditions are associated with a sub acute chronic inflammatory process and activation of an important inflammatory signaling pathway involving IKKb/NF-kB. Salicylates, medications related to aspirin, can inhibit the IKKb-NF-kB pathway and studies in rodents and people suggest this may be a useful target and class of drugs to treat patients with diabetes. High doses of aspirin are associated with risk of bleeding. We are studying a form of salicylate, called salsalate, which has a lower risk of bleeding and has previously been used in people with arthritis type chronic pain. In this multicenter double masked placebo controlled parallel study we will evaluate targeting inflammation using salsalate in the treatment of type 2 diabetes. The overall primary objective of the study is to determine whether salicylates represent a new pharmacological option for diabetes management. The study is conducted in twos stages. The primary objective of the first stage is to select a dose of salsalate that is both well tolerated and demonstrates a trend toward improvement in glycemic control. The primary objective of stage 2 is to determine whether salicylates represent a new pharmacological option for diabetes management.The implementation of the second stage is predicated on the successful selection of a dose in the first stage.
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