GH markers

Code: R16SC02SM

To analyze biological samples using SomaLogic's proprietary SOMAscan™ proteomic assay with the objective of potential discovery of new biomarkers of hGH abuse. The services will be provided in accordance with the terms and conditions set forth in the Standard SOMAscan Services Agreement attached hereto as Exhibit A.

Main findings

As shown in this study, hGH treatment results in detectable changes of SOMAmer-targeted protein analytes. Across the 10-day study period, some analytes exhibit a quadratic, or squared-type change, which generally track the hGH treatment period. Such parabolic responses that have a maximum or minimum at Day 4, and then return toward baseline levels by day 10, represent analytes that change during the administration of hGH, such as those theorized or observed in the previous WADA/SomaLogic pilot study. However, analytes discovered via a quadratic model in which measurement levels return to baseline within 6 days do not represent detectable differences > 6 days after treatment has stopped. The linear models in Section 4.2 show targets that change across the entire 10 day period, remaining elevated (or depressed) several days post-treatment. Finally, the actual magnitude of change at different timepoints may be important. For this reason, this report includes log2 of fold-change compared to baseline at several key timepoints, as well as test statistics from paired Student’s t-tests. These “key” timepoints include baseline vs. 8 hours (the initial post-treatment follow-up), baseline vs. Day 4 (the final treatment day), and baseline vs. Day 10 (the final study day). The 8-hour analysis shows the highest number of significant analyte changes, but the metabolic targets (e.g. insulin and pancreatic hormone) are suggestive of a potential post-prandial effect. The Day 10 analysis shows the least number of significant changes. The paired analysis results should be combined with the linear mixed-model (quadratic or linear) results to suggest protein targets that have plausible magnitude and directional changes as well as longitudinal trends. To this end, FDR and Bonferroni-adjusted p-values are provided, as well as unadjusted p-values are provided in the external spreadsheet “WADA_SomaLogic_HGH.xlsx”). Appropriate usage of statistically-significant results, combined with specific treatment hypotheses and biological knowledge should be combined holistically and purposefully. This report contains annotated visualizations, as well as the combined, interactive spreadsheet mentioned above, to aid in hypothesis testing so that trade-offs can be made between model type, false discovery, and particular protein targets of interest.