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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 中心，不一定是研究者的机构。 本研究将评估和跟踪 1 型糖尿病 (T1DM) 患者的一级和二级亲属，以表征他们患 T1DM 的风险，研究抗体阳性亲属中进展为 T1DM 的自然史，并识别处于风险中的受试者T1DM 参与与预防 T1DM 相关的临床试验。 本研究分为三个阶段。 在第一阶段（筛查）期间，受试者将获得一份血液样本用于测定胰岛细胞抗体，如果第一份样本呈阳性，则将获得第二份样本以确认抗体。 在第 2 阶段（基线评估）期间，胰岛细胞抗体阳性受试者将进行风险评估，包括确认胰岛细胞抗体状态（如有必要）、HLA 分型、口服葡萄糖耐量测试 (OGTT)、血红蛋白 A1c (HbA1c) 以及某些情况下的风险评估。病例进行静脉葡萄糖耐量试验（IVGTT）。 在第 3 阶段（后续评估）期间，参与者将每 6 个月测定一次抗体、HbA1c 和一次 OGTT，以确定他们是否患有糖尿病并跟踪进展为糖尿病的自然史。 1 型糖尿病预防试验（DPT-1；现已结束）的前参与者将直接进入第 3 阶段，因为他们在参与 DPT-1 期间已被证明患有 T1DM 的风险较高。 参与本方案第 3 阶段且有资格参加 TrialNet 糖尿病预防试验（本文未描述）的受试者可以退出本研究。