TRIALNET HISTORY STUDY OF THE DEVELOPMENT OF TYPE I DIABETES

I 型糖尿病发展的 Trialnet 历史研究

• 批准号: 7603401
• 负责人: Neil H. White
• 金额: $ 0.22万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603401
• 关键词: Antibodies; Blood specimen; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Development; Diabetes Mellitus; Diabetes prevention; Enrollment; Funding; Glycosylated hemoglobin A; Grant; Institution; Insulin-Dependent Diabetes Mellitus; Natural History; OGTT; Participant; Persons; Phase; Prevention; Protocols documentation; Recording of previous events; Relative (related person); Research; Research Personnel; Resources; Risk; Risk Assessment; Sampling; Screening procedure; Second Degree Relative; Source; United States National Institutes of Health; follow-up; intravenous glucose tolerance test; islet cell antibody

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. This study will evaluate and follow first and second degree relatives of persons with type 1 diabetes mellitus (T1DM) to characterize their risk of developing T1DM, to study the natural history of progression to T1DM among antibody-positive relatives, and to identify subjects at risk for T1DM for participation in clinical trials related to the prevention of T1DM. This study is divided into three phases. During Phase 1 (screening), subjects will have a single blood sample for determination of islet cell antibodies and a second sample to confirm antibodies if the first sample was positive. During Phase 2 (baseline assessment), islet cell antibody positive subjects will have a risk assessment done including confirmation of islet cell antibody status (if necessary), HLA typing, oral glucose tolerance test (OGTT), hemoglobin A1c (HbA1c) and in some cases an intravenous glucose tolerance test (IVGTT). During Phase 3 (follow-up assessments), participants will have determination of antibodies, and HbA1c and an OGTT every 6 months to determine if they have developed diabetes and to follow the natural history of progression to diabetes. Former participants in the Diabetes Prevention Trial-Type 1 Diabetes (DPT-1; now closed) will be enrolled directly into Phase 3 since they have already been demonstrated to be at higher risk for T1DM during their participation in DPT-1. Subjects participating in Phase 3 of this protocol who are eligible for participation in a TrialNet diabetes prevention trial (not described herein) may be withdrawn from this study.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 本研究将评估和跟踪1型糖尿病(T1 DM)患者的一级和二级亲属，以确定他们患T1 DM的风险特征，研究抗体阳性亲属进展为T1 DM的自然病史，并确定T1 DM的高危人群，以参与与T1 DM预防相关的临床试验。本研究分为三个阶段。在第一阶段(筛查)中，受试者将接受单一血液样本检测胰岛细胞抗体，如果第一个样本呈阳性，则进行第二个样本以确认抗体。在第二阶段(基线评估)，胰岛细胞抗体阳性的受试者将接受风险评估，包括确认胰岛细胞抗体状态(如有必要)、人类白细胞抗原配型、口服葡萄糖耐量试验(OGTT)、血红蛋白A1c(HbA1c)，在某些情况下还包括静脉葡萄糖耐量试验(IVGTT)。在第三阶段(后续评估)，参与者将每6个月进行一次抗体、糖化血红蛋白和OGTT的测定，以确定他们是否患上了糖尿病，并跟踪糖尿病的自然发展史。糖尿病预防试验-1型糖尿病(DPT-1；现已关闭)的前参与者将直接登记进入第三阶段，因为他们在参与DPT-1期间已被证明患有T1糖尿病的风险更高。参与该方案第三阶段的有资格参加TrialNet糖尿病预防试验(未在此描述)的受试者可以退出这项研究。