DURATION OF THE HONEYMOON PHASE OF TYPE 1 DIABETES:

1 型糖尿病蜜月期的持续时间：

基本信息

批准号：
7606357
负责人：
PERRIN C WHITE
金额：
$ 0.06万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
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/7606357
关键词：
Address Affect Age Age of Onset Autoimmune Process Beta Cell Biological Preservation C-Peptide Cell physiology Child Computer Retrieval of Information on Scientific Projects Database Condition Confounding Factors (Epidemiology)Data Development Diabetes Mellitus Diagnosis Disease Funding Future Glycosylated hemoglobin A Grant Growth and Development function Hyperglycemia Institution Insulin Insulin-Dependent Diabetes Mellitus Intervention Intervention Studies Islets of Langerhans Measures Morbidity - disease rate Newly Diagnosed Normal Pressure Hydrocephalus Numbers Outcome Pancreas Patients Persons Phase Randomized Controlled Clinical Trials Research Research Personnel Residual state Resources Source Testing Time Treatment Protocols United States United States National Institutes of Health absorption aged analog glargine glycemic control improved mortality

项目摘要

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. Type 1 diabetes is a very common disorder affecting 1/400 persons by the age of 18 years in the United States alone. It is responsible for a disproportionate percentage of the morbidity and mortality associated with diabetes because of its typically young age of onset and difficulty achieving good glycemic control. Although exogenous administration of insulin allows for normal growth and development in children with this condition, it is not a cure. Studies which have attempted to modify the autoimmune process which underlies the development of hyperglycemia in patients with type 1 diabetes have focused on the preservation of the innate insulin secretory capacity of the endocrine pancreas as the primary outcome variable. Interventions that might preserve residual beta-cell function and thereby improve glycemic control have the potential to have significant effects on long-term morbidity and mortality. In recent years, a number of insulin analogs have been developed which have varying time-action profiles due to varying mechanisms of absorption. In comparison to children on the moderate-acting analog NPH, we have retrospective data to suggest that children placed on the long-acting analog glargine achieve significantly better average glycemic control for at least the first nine months after diagnosis of type 1 diabetes. This contrasts to children with long-standing diabetes who are switched from NPH to glargine, who show no significant change in average glycemic control as measured by Hemoglobin A1c values. Therefore, we propose a randomized trial of insulins glargine and NPH in patients aged 6-18 years newly diagnosed with type 1 diabetes to address whether this difference is due to better preservation of the innate insulin secretory capacity of the pancreas. In order to evaluate whether there is a differnece in insulin reserve between patients treated with glargine vs NPH, we will perform mixed meal tolerance tests at study entry and again at 6 and 12 months, with C-peptide secretion as the primary outcome variable. If a difference is found, this could have significant implications for future intervention studies in patients with type 1 diabetes, as failing to control for insulin regimen could be a potential confounding variable in such studies.

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。列出的机构是对于中心来说，它不一定是研究者的机构。 1 型糖尿病是一种非常常见的疾病，仅在美国就有 1/400 18 岁以下的人受到影响。由于糖尿病通常发病年龄较小且难以实现良好的血糖控制，因此它在与糖尿病相关的发病率和死亡率中所占比例过高。尽管外源性注射胰岛素可以使患有这种疾病的儿童正常生长和发育，但它并不能治愈。试图改变 1 型糖尿病患者发生高血糖的自身免疫过程的研究集中于保留内分泌胰腺的先天胰岛素分泌能力作为主要结果变量。可能保留残余β细胞功能并从而改善血糖控制的干预措施有可能对长期发病率和死亡率产生显着影响。近年来，已经开发了许多胰岛素类似物，它们由于不同的吸收机制而具有不同的时间作用曲线。与服用中效类似物 NPH 的儿童相比，我们的回顾性数据表明，服用长效类似物甘精胰岛素的儿童至少在诊断 1 型糖尿病后的前 9 个月内实现了显着更好的平均血糖控制。这与患有长期糖尿病的儿童从 NPH 转为甘精胰岛素形成对比，根据血红蛋白 A1c 值测量，这些儿童的平均血糖控制没有显着变化。因此，我们建议对 6-18 岁新诊断 1 型糖尿病患者进行甘精胰岛素和 NPH 的随机试验，以探讨这种差异是否是由于更好地保存了胰腺先天胰岛素分泌能力所致。为了评估接受甘精胰岛素治疗的患者与接受 NPH 治疗的患者之间的胰岛素储备是否存在差异，我们将在研究开始时以及第 6 个月和 12 个月时进行混合膳食耐受性测试，以 C 肽分泌作为主要结果变量。如果发现差异，这可能会对未来 1 型糖尿病患者的干预研究产生重大影响，因为未能控制胰岛素治疗方案可能是此类研究中潜在的混杂变量。