TrialNet: University of Florida Clinical Center and Network

TrialNet：佛罗里达大学临床中心和网络

基本信息

批准号：
8831775
负责人：
DESMOND Arthur SCHATZ
金额：
$ 2.02万
依托单位：
UNIVERSITY OF FLORIDA
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2014-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8831775
关键词：
Activities of Daily Living Antigens Antithymoglobulin Autoantibodies Autoimmune Diseases B-Lymphocytes Beta Cell Biological Assay Blood Glucose C-Peptide CSF3 gene Candida Cell physiology Cells Clinical Combined Modality Therapy Comparative Study Data Dendritic Cells Development Diabetes Mellitus Dietary Intervention Disease Disease Progression Dose Florida Flow Cytometry Frequencies Glucagon Glutamate Decarboxylase Granulocyte Colony-Stimulating Factor Health Human IA-2-autoantibody Immune response Immunity Immunization Immunologics Inbred NOD Mice Incidence Individual Insulin Insulin-Dependent Diabetes Mellitus Intervention Islet Cell Islets of Langerhans MS4A1 gene Metabolic Monitor Natural History Newly Diagnosed Oral Patients Physicians Pilot Projects Population Principal Investigator Production Protocols documentation Regulatory T-Lymphocyte Research Design Safety Serum Societies T-Lymphocyte Tetanus Therapeutic Intervention Transplantation United States National Institutes of Health Universities Work base blood glucose regulation cytokine diabetes mellitus genetics disorder prevention follow-up insulin secretion islet mycophenolate mofetil peripheral blood prevent randomized placebo controlled trial validation studies

项目摘要

DESCRIPTION (provided by applicant): The University of Florida intends to continue as a Clinical Center as part of the nationally constituted diabetes trial network (Type 1 Diabetes TrialNet), in order to ultimately study therapies aimed at preventing or delaying the development of type 1 diabetes (T1D). The University of Florida Clinical Center has participated in nine approved NIH TrialNet protocols including the Natural History Study, the Mycophenolate Mofetil (MMF) / Dacluzimab (DZB) Trial, the Anti-CD20 Trial, the CTLA-4 lg Trial, the Oral Insulin Study, the comparative Mixed Meal Tolerance (MMTT) - Glucagon Stimulation (GST) C-peptide Study, the T-Cell Assay Validation Study, the Nutrition Intervention to Prevent Diabetes (NIP) Study, and the T1D Genetics Consortium. The Center has consistently been one of the strongest performers both in the recruitment of subjects and the conduct of TrialNet (and other Type 1 studies) and will work to continue oversight of its successful network of Affiliate Centers and participating physicians involved in TrialNet study recruitment and follow-up and to further expand these efforts. We intend to continue to conduct studies in patients with recent-onset diabetes aimed at preserving beta cell function and/or decreasing beta cell destruction, and, if safety and efficacy is demonstrated, implement studies using these agents aimed at the prevention of the disease. Based on (i) exciting preliminary (efficacy, mechanistic and safety) data using a combination of low-dose Anti-Thymocyte Globulin (ATG) and Granulocyte Colony Stimulating Factor (GCSF) in NOD mice, (ii) encouraging data in other human autoimmune disorders and transplantation (iii) pilot studies using each agent separately in new-onset patients, we propose to conduct a study aimed at establishing the safety, efficacy and mechanism of this combination as an intervention to slow disease progression in individuals with newly-diagnosed T1D.

描述（由申请人提供）：佛罗里达大学打算继续作为临床中心，作为全国组成的糖尿病试验网络（1型糖尿病试验网络）的一部分，以最终研究旨在预防或延迟1型糖尿病（T1D）发展的研究疗法。佛罗里达大学临床中心已参加了九项批准的NIH试验NIH试验方案，包括自然史研究，霉酚酸酯莫菲蒂（MMF） / dacluzimab（DZB）试验，抗CD20试验，抗CD20试验，CTLA-4 LG试验，CTLA-4 LG试验，《口服胰岛素研究》，《比较混合饮食》（MMMMMT）（MMMMT） - gluct caster the carte carte（mmmmt）， T细胞测定验证研究，预防糖尿病研究（NIP）研究的营养干预和T1D遗传联盟。该中心一直是招聘受试者和试验网（以及其他1型研究）的表现最强的人之一，并将继续监督其成功的会员中心网络以及参与试用网研究招聘和随访的参与医生，并进一步扩大这些努力。我们打算继续对旨在保存β细胞功能和/或减少β细胞破坏的近期糖尿病患者进行研究，如果证明了安全性和功效，则使用旨在预防疾病的这些药物实施研究。基于（i）使用低剂量抗心理细胞球蛋白（ATG）（ATG）和粒细胞群刺激因子（GCSF）的组合，基于（i）令人兴奋的初步（功效，机械和安全性）数据，（ii）使用人类自身免疫性疾病和移植研究的其他目标（iii）促进了新的行为（iii），以启用了新的行为（III），以启用了新的企业（iii）。建立这种组合的安全性，功效和机制，以减缓新诊断为T1D的个体疾病进展的一种干预措施。