In the past year, we have obtained final IRB approval for this clinical protocol, Assessment of the Effects of A DPP-4-Specific Inhibitor (Sitagliptin/Januvia) On Immune Function In Healthy Individuals. In January, the protocol number, 09DK-0055, was assigned. The first participant was enrolled in April. By the end of FY09, a total of 8 volunteers will have been enrolled, and 3 volunteers will have finished the study. An additional 7 individuals have completed questionnaires that have been reviewed to fit within the study inclusion/ exclusion criteria. These individuals will be scheduled for screening visits/ potential enrollment this fall. The research study assays are ongoing. For all study visits to date, flow cytometry assays have been performed on PBMCs. Other immune assays are being done once each volunteer has completed all 6 study visits.
Decalf, Jérémie; Tarbell, Kristin V; Casrouge, Armanda et al. (2016) Inhibition of DPP4 activity in humans establishes its in vivo role in CXCL10 post-translational modification: prospective placebo-controlled clinical studies. EMBO Mol Med 8:679-83 |
Price, J D; Linder, G; Li, W P et al. (2013) Effects of short-term sitagliptin treatment on immune parameters in healthy individuals, a randomized placebo-controlled study. Clin Exp Immunol 174:120-8 |