DURATION OF THE HONEYMOON PHASE OF TYPE 1 DIABETES:

1 型糖尿病蜜月期的持续时间：

• 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
• 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

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 1型糖尿病是一种非常普遍的疾病，仅在美国就在18岁时就会影响1/400人。 由于其通常年轻的发病年龄和难以实现良好的血糖控制，因此它导致与糖尿病相关的发病率和死亡率的比例不成比例。尽管胰岛素的外源性施用允许患有这种情况的儿童的正常生长和发育，但这不是治愈方法。 试图改变自身免疫过程的研究是1型糖尿病患者高血糖发展的基础的研究，重点是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。可能保留残留β细胞功能并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重大影响。 近年来，由于吸收的机制不同，已经开发了许多胰岛素类似物，它们具有不同的时间行动曲线。与中等作用类似物NPH的儿童相比，我们有回顾性数据，表明将置于长效类似物的甘甘葡萄碱上的儿童至少在诊断为1型糖尿病后的前九个月中，平均血糖控制明显更好。 这与长期糖尿病的儿童从NPH转换为甘醇葡萄碱的儿童形成鲜明对比，这些儿童通过血红蛋白A1C值衡量，他们在平均血糖控制中没有显着变化。 因此，我们提出了6-18岁的新诊断患有1型糖尿病的患者的胰岛素和NPH的随机试验，以解决这种差异是否是由于更好地保存胰腺的先天胰岛素分泌能力。 为了评估接受甘胶治疗的患者与NPH治疗的患者之间的胰岛素储备是否有不同，我们将在研究入学时进行混合餐饮测试，并在6和12个月时再次进行C肽分泌作为主要结果可变。 如果发现差异，这可能对1型糖尿病患者的未来干预研究产生重大影响，因为在此类研究中未能控制胰岛素方案可能是一种潜在的混杂变量。