{"id":7108,"date":"2022-10-17T04:09:22","date_gmt":"2022-10-17T11:09:22","guid":{"rendered":"https:\/\/www.breakthrought1d.org\/pacificnwandseattleguild\/?p=7108"},"modified":"2025-12-01T20:28:49","modified_gmt":"2025-12-01T20:28:49","slug":"t1d-clinical-trial-highlight-the-topple-study-at-the-benaroya-research-institute","status":"publish","type":"post","link":"https:\/\/www.breakthrought1d.org\/greaternorthwest\/2022\/10\/17\/t1d-clinical-trial-highlight-the-topple-study-at-the-benaroya-research-institute\/","title":{"rendered":"T1D Clinical Trial Highlight : The TOPPLE Study at the Benaroya Research Institute"},"content":{"rendered":"<p>Did you know<em>\u2026.<\/em> that 80% of clinical trials are delayed or terminated because of slow or low patient enrollment?\u00a0 Without clinical trials, scientists cannot verify new discoveries and pharmaceutical companies and other sponsors have less incentive to support advancing research.<\/p>\n<p>Thankfully, you can help!\u00a0 Each month, we will highlight a clinical trial that is recruiting in our chapter or share information about the research institutions available to us in the Pacific Northwest.\u00a0 We believe that, as you learn about ongoing research, you will be heartened by the progress being made towards improved treatment and cures for T1D.\u00a0 We also hope that those of you living with T1D will be empowered to participate in one or more trials yourself.<\/p>\n<p>This month, we would like to highlight the TOPPLE Study, a trial being run at the Benaroya Research Institute (BRI) in Seattle.<\/p>\n<p>TOPPLE STUDY<\/p>\n<p><strong>Study Name<\/strong>: TOPPLE Study<br \/>\n<strong>Principal Investigator<\/strong>: Carla Greenbaum, MD<br \/>\n<strong>Phone<\/strong>: 1-800-888-4187<br \/>\n<strong>Email<\/strong>:\u00a0<a href=\"mailto:diabetes@benaroyaresearch.org?subject=TOPPLE%20Study%20Inquiry\">Diabetes@BenaroyaResearch.org<\/a><\/p>\n<p>WHAT IS THE TOPPLE STUDY?<\/p>\n<p>This is a TrialNet study testing the safety and dosing of a new plasmid therapy in adults ages 18 &#8211; 45 who have been diagnosed with type 1 diabetes within the past four years. A plasmid is a circular piece of DNA that can deliver therapy into cells where it can communicate with the immune system.\u00a0 The goal is to help \u201cre-educate\u201d the immune system to stop destroying insulin-producing cells in the pancreas which leads to type 1 diabetes.<\/p>\n<p>While plasmids are small circular pieces of DNA, they do not change your DNA. They are currently being studied in many clinical trials for other conditions.<\/p>\n<p>Study\u00a0Lead Investigator Robin Goland, M.D., Columbia University,\u00a0New York,\u00a0explains, \u201cThere are some promising new areas of study directed at trying to delay, prevent, and eventually cure T1D. Using plasmids to deliver antigen therapy directly to cells to impact this immune system\u00a0is an exciting new area that can\u00a0potentially\u00a0be moved toward prevention.\u201d<\/p>\n<p>Earlier studies in the lab show this treatment might retrain the immune system to stop attacking insulin-producing beta cells.\u00a0 The TOPPLE study is a phase 1 study because this is the first time this particular plasmid is being tested in people.<\/p>\n<p>As with any medical intervention, there are risks and benefits to participating in this study. Before you decide to participate, a member of BRI\u2019s study team will explain all potential risks and benefits and answer any questions you may have.<\/p>\n<p>WHAT WILL STUDY PARTICIPANTS BE ASKED TO DO?<\/p>\n<p>All study visits take place at Benaroya Research Institute\u2019s clinical research center in Seattle. Participants receive a stipend for study visits, parking is free and travel expenses are covered for those living outside the Seattle area.<\/p>\n<p>A benefit of participating in a new-onset study is the personalized coaching in T1D management participants receive from the study team.<\/p>\n<p>The study has two phases: treatment and follow-up.\u00a0 In the treatment phase, participants will visit BRI\u2019s clinical research center weekly for 12 weeks. In the follow-up phase, participants will have a study visit at months 3, 4, 6 and 12.<\/p>\n<p>Says Dr. Goland,\u00a0\u201cAn important\u00a0point of\u00a0any\u00a0phase 1\u00a0study is to help us\u00a0understand the safety of the therapy.\u00a0In this study, we also aim to learn about how the therapy\u00a0affects\u00a0the immune system.\u00a0Armed with this information,\u00a0we\u00a0plan\u00a0to\u00a0move forward with\u00a0a larger\u00a0study\u00a0to see if\u00a0this therapy\u00a0can\u00a0delay\u00a0or stop T1D\u00a0before clinical diagnosis. That\u2019s how great discoveries are made.\u201d<\/p>\n<p>HOW CAN I PARTICIPATE OR FIND OUT MORE?<\/p>\n<p>To learn more about this study or find out if you\u2019re eligible, please contact BRI at 800-888-4187 or email\u00a0<a href=\"mailto:diabetes@benaroyaresearch.org?subject=TOPPLE%20Study%20Inquiry\">Diabetes@BenaroyaResearch.org<\/a> or scan this QR code:<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/www.breakthrought1d.org\/greaternorthwest\/wp-content\/uploads\/sites\/171\/2022\/10\/Topple-Study.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-7110\" src=\"https:\/\/www.breakthrought1d.org\/greaternorthwest\/wp-content\/uploads\/sites\/171\/2022\/10\/Topple-Study.png\" alt=\"\" width=\"232\" height=\"235\" \/><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Did you know\u2026. that 80% of clinical trials are delayed or terminated because of slow or low patient enrollment?\u00a0 Without clinical trials, scientists cannot verify new discoveries and pharmaceutical companies and other sponsors have less incentive to support advancing research.&hellip;<\/p>\n","protected":false},"author":1317,"featured_media":7090,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ep_exclude_from_search":false,"publish_on_app_meta":"True","iawp_total_views":11,"footnotes":"","bt1d_storytelling_post":false,"bt1d_storytelling_more_posts":[]},"topics":[31],"class_list":["post-7108","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","jdrf_topic-clinical-trials"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>T1D Clinical Trial Highlight : The TOPPLE Study at the Benaroya Research Institute - Greater Northwest Chapter<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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