CLINICAL TRIAL: THE ROLE OF EXENATIDE IN TYPE I DIABETES MELLITUS

临床试验：艾塞那肽在 I 型糖尿病中的作用

• 批准号: 7950635
• 负责人: RUBINA A HEPTULLA
• 金额: $ 1.01万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950635
• 关键词: Adolescent; Adult; Animals; Apoptosis; Beta Cell; Cell Survival; Childhood; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Diabetes Mellitus; Diagnosis; Dietary Carbohydrates; Dose; Funding; Gastric Emptying; Gastroparesis; Glucagon; Glucose; Grant; Hyperglycemia; Hypoglycemia; Institution; Insulin; Insulin-Dependent Diabetes Mellitus; New Agents; Patients; Pramlintide; Property; Protocols documentation; Randomized; Reporting; Research; Research Personnel; Resources; Role; Source; Testing; United States National Institutes of Health; analog; exenatide; glucagon-like peptide 1; glycemic control; hyperglucagonemia; improved; islet amyloid polypeptide

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 mellitus (T1DM) is currently managed using modulation of dietary carbohydrates and insulin. Parasoxical post-meal hyperglucagonemia is associated with psot-prandial hyperglycemia in T1DM. Glucagon suppressors such as the amylin analog, pramlintide, and the glucagon like peptide-1 (GLP-1) analog, exenatide, are new agents approved for use in adults with diabetes. We have previously demonstrated pramlintide reduces post-prandial hyperglycemia by decreasing glucagon and delaying gastric emptying in adolescents with T1DM. GLP-1 in animal studies has been shown to increase beta cell mass and decrease apoptosis. Only limited information is available on the use of GLP-1 in T1DM. No studies have been reported to determine if pramlintide and exenatide have similar effects on glycemic control in T1DM. The overall aim of this proposal is to develop safe and effective strategies targeting glucagon and improving glycemic control in T1DM. The overall aim of this proposal is to develop safe and effective strategies targeting glucagon and improving glycemic control in pediatric T1DM. The specific aim of Protocol 1 is to establish a glucose-lowering dose of exenatide in T1DM equivalent to that which we have established for pramlintide. To this end 17 subjects with T1DM will be randomized to 4 studies with varying pramlintide doses. Glucagon suppression and delay in gastric emptying will also be assessed. Higher doses of exenatide will result in more pronounced effects on gastric emptying and glucagon suppression as compared to lower doses. SPECIFIC AIMS To establish an effective dose of exenatide, which will normalize post-prandial hyperglycemia without causing hypoglycemia. To determine the effects of exenatide on gastric emptying and glucagon suppression. The long-term objective of this protocol is to develop a safe exenatide dose that can be used in new onset patients with T1DM. The antiapoptic properties of exenatide will be tested to determine if using exenatide early in the diagnosis prolongs beta cell survival and hence prolonging of the honeymoon period of diabetes.

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（T1DM）目前是使用饮食碳水化合物和胰岛素的调节来管理的。 寄生虫后高葡萄糖血症与T1DM中的PSOT-丙型高血糖有关。 胰高血糖素抑制剂，例如氨基蛋白类似物，pramlintide和胰高血糖素（如肽-1（GLP-1）类似物），是艾鉴定的，是批准用于糖尿病成人的新药物。 我们以前曾证明，pramlintide通过减少胰高血糖素并延迟T1DM青少年的胃排空来降低餐后高血糖。 在动物研究中，GLP-1已显示可增加β细胞量并减少凋亡。 只有在T1DM中使用GLP-1的有限信息。 尚无据报道，确定pramlintide和Etenatide对T1DM中血糖控制的影响是否相似。 该提案的总体目的是制定针对胰高血糖素和改善T1DM血糖控制的安全有效策略。 该提案的总体目的是制定针对胰高血糖素的安全有效策略，并改善小儿T1DM的血糖控制。 方案1的具体目的是在T1DM中建立降糖剂量的降温剂量，等同于我们为pramlintide建立的升温剂量。 在此末尾，具有T1DM的17名受试者将被随机分为4个研究，并具有不同的pramlintide剂量。 胰高血糖素抑制和胃排空的延迟也将评估。 与较低剂量相比，更高剂量的艾替肽会对胃排空和胰高血糖素的抑制产生更明显的影响。 具体目标 建立有效剂量的艾替肽，该剂量将使餐后高血糖量化，而不会引起低血糖。 确定艾烯肽对胃排空和胰高血糖素抑制的影响。 该方案的长期目的是开发可用于T1DM的新发作患者的安全大丝剂剂量。 将测试EteNatide的抗抗原特性，以确定在诊断中早期使用Etenatide是否会延长β细胞存活，从而延长糖尿病的蜜月期。