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。 本研究将评价和随访1型糖尿病（T1 DM）患者的一级和二级亲属，以描述其发生T1 DM的风险，研究抗体阳性亲属进展为T1 DM的自然史，并确定有T1 DM风险的受试者参加与预防T1 DM相关的临床试验。 本研究分为三个阶段。 在第1阶段（筛选）期间，受试者将获得一份用于测定胰岛细胞抗体的血液样本，如果第一份样本为阳性，则获得第二份样本以确认抗体。 在II期（基线评估）期间，将对胰岛细胞抗体阳性受试者进行风险评估，包括确认胰岛细胞抗体状态（如有必要）、HLA分型、口服葡萄糖耐量试验（OGTT）、血红蛋白A1 c（HbA 1c）和某些情况下的静脉葡萄糖耐量试验（IVGTT）。 在第3阶段（随访评估）期间，受试者将每6个月测定一次抗体和HbA 1c以及OGTT，以确定他们是否已患糖尿病并随访糖尿病进展的自然史。 糖尿病预防试验-1型糖尿病（DPT-1;现已关闭）的前参与者将直接入组III期研究，因为他们在参与DPT-1期间已被证明具有较高的T1 DM风险。 参加本方案III期的受试者，如果有资格参加TrialNet糖尿病预防试验（本文未描述），则可能退出本研究。