CLINICAL TRIAL: TYPE 1 DIABETES TRIALNET - MMF/DZB

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 在过去的10-20年里，大量的证据表明，人类的1型糖尿病是一种慢性的、缓慢进行的自身免疫性疾病。本研究的目的是确定免疫干预策略，以防止从1型糖尿病发作时β细胞破坏的进展。至少一些β细胞的持续存在应该改善长期糖尿病护理，不仅可以预防疾病本身的并发症，还可以预防低血糖，这是其管理的结果。目的是阻止新糖尿病受试者中的β细胞破坏，因为一旦自身免疫过程进展到导致明显疾病，免疫调节可能无法单独良好地工作。该研究的基本原理是证明在本研究的4年过程中，胰岛功能得到了有意义的保护，免疫系统影响最小。如果结果足够积极，该临床试验的数据可以作为更大规模试验的基础，或者它们可以建议其他联合干预试验，这些试验可能会获得更好的疗效或可能保留C肽而无需继续免疫抑制。长期糖尿病的并发症是众所周知的，并且目前每年护理糖尿病及其并发症的费用超过100亿美元。DCCT和其他研究表明，改善代谢控制可以减少糖尿病的长期并发症[6]。因此，可以恢复正常胰岛功能并维持胰岛素产生的干预措施将显著改善糖尿病代谢控制的预后，从而减少长期并发症。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The great body of evidence developed over the last 10-20 years suggests that type 1 diabetes in humans is a chronic, slowly progressive autoimmune disease. The objective of this study is to identify immune intervention strategies that will prevent the progression of beta cell destruction from the time of onset of type 1 diabetes. The persistence of at least some beta cells should improve long-term diabetes care and prevent not only complications of the disease itself but also hypoglycemia, which is a consequence of its management. The aim is to arrest beta cell destruction in newly diabetic subjects because immune modulation may not work well alone once the autoimmune process has progressed so far as to result in overt disease. The study's rationale is to demonstrate a meaningful preservation of islet function with minimal immune system effects over the 4-year course of this study. The data from this clinical trial could serve as the basis for a larger trial if the results are sufficiently positive, or they could suggest other combined interventiontrials that might achieve either better efficacy or potentially preserve C-peptide without the need for continued immunosuppression. The complications of long-term diabetes are well known, and the costs of caring for diabetes and its complications are currently greater than 0 billion a year. The DCCT and other studies have demonstrated that improved metabolic control can reduce the long-term complications of diabetes [6]. Thus, an intervention, which could restore normal islet function and maintain production of insulin would significantly improve the prognosis for metabolic control of diabetes and thus reduce long-term complications.