Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy-TINSAL -T1DN
Diabetic neuropathy (DN) is the most common chronic complication of diabetes, affecting up to50% of individuals with type 1 diabetes (T1DM). Multiple pre-clinical and clinical studies demonstrate a pathogenic role for inflammation, especially cytokine production, in the disease course of DN and CAN. This suggests that agents with known anti-inflammatory properties, such as salicylates, may prevent the development of DN and the pain associated with DN. This study builds upon and expands on prior work done by the investigators with salsalate, a pro-drug form of salicylate, as an agent to address inflammatory pathways in people with T1DM.
• T1DM;
• age 18-70;
• mild DN as defined by symptoms and/or signs, confirmed by at least one abnormality in electrophysiology studies (abnormality of at least one attribute among conduction velocity, latency, amplitude or F-Wave in at least one nerve among sural sensory, ulnar sensory, or peroneal motor);
• sural nerve amplitude \> 0 μV. If sural nerve amplitude is 0 μV (unrecordable) peroneal motor nerve conduction velocity must be ≥ 35 m/second\*;
• on a stable insulin regimen for the 3 months prior to enrollment;
• be willing and capable of signing the IRB approved consent form and willing and able to cooperate with the medical procedures for the study duration;
• be willing to accept random treatment assignment to salsalate or placebo; and
• women of childbearing age agree to use an appropriate contraceptive method (hormonal, IUD, or diaphragm) for the duration of the study and must have a negative urine pregnancy test at screening.