| Outcome Measures: |
Primary: Impact on insulin secretion determined by 2-hour MMTT stimulated AUC C-peptide 10 weeks after first vedolizumab dose and 52 weeks after randomization., MMTT-Stimulated 2-Hour C-peptide AUC is the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test., baseline dose to 10 weeks and baseline dose to 52 weeks|Adverse events of etanercept treatment as a measure of safety and tolerability, An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Results will be reported as a rate of each adverse event, baseline to 52 weeks|Adverse events of vedolizumab treatment as a measure of safety and tolerability, An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Results will be reported as a rate of each adverse event, baseline to 52 weeks | Secondary: Frequency of α4β7+ T cells, Cell phenotype will be measured as a percentage using either flow cytometry or cytometry by time of flight (CyTOF), via an assay such as the AIM (Activation-Induced Marker) assay., baseline to 52 weeks|Frequency of myeloid DC1 cells, Cell phenotype will be measured as a percentage using either flow cytometry or cytometry by time of flight (CyTOF), via an assay such as the AIM (Activation-Induced Marker) assay., baseline to 52 weeks|Frequency and surface marker phenotype of other immune cells such as antigen specific CD4 and CD8 cells, memory and naive T and B cells, Cell phenotype will be measured as a percentage using either flow cytometry or cytometry by time of flight (CyTOF), via an assay such as the AIM (Activation-Induced Marker) assay., baseline to 52 weeks|Change in T1D antibody titers, T1D autoantibodies include: mIAA, GAD-65, IA-2, ZnT8, as reported in international units per mililiter, baseline to 52 weeks
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| Locations: |
University of California San Diego, La Jolla, California, 92037, United States|Benaroya Research Institute, Seattle, Washington, 98102, United States
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