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)： 胃瘫患者经常出现慢性胃肠道症状，这些症状得不到充分治疗，部分原因是对潜在的病理生理学缺乏了解，部分原因是缺乏有效的治疗。坦普尔大学胃肠动力中心参与NIH/NIDDK胃瘫临床研究联盟和拟议的研究将有助于实现改善胃瘫患者诊断和治疗的广泛、长期目标。坦普尔非常有资格成为该联盟的临床中心之一。坦普尔公司在评估和治疗胃瘫患者方面拥有临床专业知识和积极的研究计划。 我们的短期研究方案旨在测试肉毒杆菌毒素注射到幽门改善消化不良症状和加速胃排空的假设，这些患者可以通过生理测试来确定。我们提出了一项前瞻性、多中心、随机、安慰剂对照、双盲研究来评估肉毒杆菌毒素对症状和胃排空的疗效。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、幽门基线压力、性别和特定的症状特征。 我们的长期研究计划是一项对胃瘫患者进行的纵向队列研究，旨在了解胃瘫患者症状恶化的原因并改进治疗。在这项研究中，将使用基于互联网的远程医疗系统定期跟踪患者的症状。这将允许遵循几个可能导致症状恶化的先行因素，包括血糖控制、饮食摄入、心理压力和炎症。此外，还将评估患者对两种药物(多潘立酮和地昔帕明)的症状反应，这两种药物可能有效改善症状，但针对不同的病理生理过程。多潘立酮是一种促动力/止吐药物，而地塞帕明是一种症状调节剂/抗抑郁药物。 拟议的方案将有助于定义可能对不同类型的胃瘫治疗有反应的患者群体。这些方案使用新的诊断测试来更好地定义胃瘫的病理生理学。这些研究也将更好地确定胃瘫患者的病程。