Temple University Gastroparesis Clinical Center

天普大学胃轻瘫临床中心

• 批准号: 7032010
• 负责人: HENRY PAUL PARKMAN
• 金额: $ 35.97万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-15 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7032010
• 关键词: antiemetics; blood glucose; botulinum toxins; clinical research; cooperative study; desipramine; diet; drug screening /evaluation; gastrointestinal agents; gastrointestinal disorder chemotherapy; gastrointestinal disorder diagnosis; gastrointestinal sign /symptom; human subject; human therapy evaluation; paralysis; patient oriented research; stomach; stomach emptying; stomach motility /pressure; telemedicine

DESCRIPTION (provided by applicant): Patients with gastroparesis often suffer with chronic gastrointestinal symptoms that are not adequately treated due, in part, to a lack of understanding of the underlying pathophysiology and due, in part, to a lack of effective treatments. The participation of Temple University Gastrointestinal Motility Center in the NIH/NIDDK Gastroparesis Clinical Research Consortium and the proposed studies will help achieve the broad, long term objectives of improving the diagnosis and treatment of patients with gastroparesis. Temple is exceptionally well qualified to be one of the clinical centers in this consortium. Temple has clinical expertise and an active research program in the evaluation and treatment of patients with gastroparesis. Our short-term study proposal is designed to test the hypotheses that botulinum toxin injection into the pylorus improves dyspeptic symptoms and accelerates gastric emptying in a subgroup of patients who can be identified with physiologic testing. We propose a prospective, multi-center, randomized, placebo- controlled, double blind study to assess the efficacy of botulinum toxin on symptoms and gastric emptying. We will analyze factors that may be predictive of a beneficial response including type and severity of gastroparesis, baseline pyloric pressure, gender, and specific symptom profiles. Our long-term study proposal is a longitudinal cohort study of patients with gastroparesis designed to understand the causes and improve the treatment of symptom exacerbations in patients with gastroparesis. In this study, patients' symptoms will be followed on a regular basis using an Internet-based telemedicine system. This will allow several antecedent factors to be followed that may be responsible for symptom exacerbation including glucose control, dietary intake, psychological stress, and inflammation. Additionally, the symptomatic response of patients to two agents (domperidone and desipramine) that may be effective in improving symptoms but target different pathophysiologic processes will be assessed. Domperidone is a prokinetic/antiemetic agent, whereas desipramine is a symptom modulator/antidepressant agent. The proposed protocols will help define patient populations that may respond to different types of treatments for gastroparesis. The protocols use novel diagnostic tests to better define the pathophysiology of gastroparesis. These studies will also better define the disease course of patients with gastroparesis

描述（由申请人提供）： 胃轻瘫的患者通常患有慢性胃肠道症状，部分原因是由于缺乏对潜在的病理生理学缺乏了解，部分原因是由于缺乏有效的治疗。 Temple University胃肠道运动中心参与NIH/NIDDK胃轻瘫临床研究联盟以及拟议的研究将有助于实现改善胃轻瘫患者诊断和治疗的广泛，长期目标。寺庙非常有资格成为该财团的临床中心之一。 Temple具有临床专业知识和一项积极的研究计划，以评估和治疗胃轻瘫患者。 我们的短期研究建议旨在测试肉毒杆菌毒素注射到幽门螺杆菌中的假设，可改善肽症状症状，并加速可以通过生理测试来鉴定的患者亚组中的胃排空。我们提出了一项前瞻性，多中心，随机，安慰剂控制的双盲研究，以评估肉毒杆菌毒素对症状和胃排空的功效。我们将分析可能预测有益反应的因素，包括胃轻瘫的类型和严重程度，基线幽门压力，性别和特定症状特征。 我们的长期研究建议是对胃轻瘫患者的一项纵向队列研究，旨在了解胃手术患者的原因并改善症状加剧的治疗。在这项研究中，使用基于Internet的远程医疗系统定期遵循患者的症状。这将允许遵循几个前身因素，这些因素可能导致症状加剧，包括控制葡萄糖，饮食摄入，心理压力和炎症。此外，将评估患者对两种可能有效改善症状的患者（domperidone和desipramine）的症状反应，但将评估针对不同的病理生理过程。 Domperidone是一种原始/抗抗毒剂，而去甲胺是症状调节剂/抗抑郁药。 提出的方案将有助于定义可能应对胃轻瘫治疗的不同类型的患者人群。该方案使用新颖的诊断测试来更好地定义胃肉食的病理生理。这些研究还将更好地定义胃轻瘫患者的疾病病程