Temple University Gastroparesis Clinical Center

天普大学胃轻瘫临床中心

基本信息

批准号：
7219967
负责人：
HENRY PAUL PARKMAN
金额：
$ 34.74万
依托单位：
TEMPLE UNIV OF THE COMMONWEALTH
依托单位国家：
美国
项目类别：
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/7219967
关键词：
Age Antidepressive Agents Antiemetics Antral Botulinum Toxins Chronic Clinical Clinical Research Clinical Research Protocols Cohort Studies Databases Desipramine Development Diagnosis Diagnostic tests Dietary intake Disease Disease remission Domperidone Double-Blind Method Electric Stimulation Evaluation Factor Analysis Functional disorder Gastric Drugs Gastric Emptying Gastrointestinal Motility Gastroparesis Gender Goals Individual Inflammation Injection of therapeutic agent Internet Investigation Lead Location Longitudinal Studies Manometry Measures Minority Multicenter Studies Numbers Patients Personal Satisfaction Pharmacologic Substance Physiological Placebo Control Population Predictive Factor Process Protocols documentation Psychological Stress Publishing Purpose Pylorus Qualifying Radionuclide Imaging Randomized Research Research Personnel Satiation Severities Stomach Structure Subgroup Symptoms System Techniques Telemedicine Testing Treatment outcome Tricyclic Antidepressive Agents United States National Institutes of Health Universities base blood glucose regulation design double-blind placebo controlled trial gastrointestinal symptom improved interest motility disorder multidisciplinary novel novel diagnostics pressure programs prospective response

项目摘要

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）：胃轻瘫患者经常患有慢性胃肠道症状，而这些症状未得到充分治疗，部分原因是缺乏对潜在病理生理学的了解，部分原因是缺乏有效的治疗方法。天普大学胃肠动力中心参与 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的诊断和治疗的广泛、长期目标。天普非常有资格成为该联盟的临床中心之一。 Temple 在胃轻瘫患者的评估和治疗方面拥有临床专业知识和积极的研究项目。我们的短期研究计划旨在测试这样的假设：将肉毒杆菌毒素注射到幽门可改善消化不良症状并加速胃排空，这些患者可以通过生理测试来识别。我们提出了一项前瞻性、多中心、随机、安慰剂对照、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、性别和具体症状特征。我们的长期研究方案是对胃轻瘫患者进行纵向队列研究，旨在了解胃轻瘫患者症状加重的原因并改善治疗。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。这将允许追踪可能导致症状恶化的几个先行因素，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/止吐剂，而地昔帕明是一种症状调节剂/抗抑郁剂。拟议的方案将有助于确定可能对不同类型的胃轻瘫治疗有反应的患者群体。该方案使用新颖的诊断测试来更好地定义胃轻瘫的病理生理学。这些研究还将更好地确定胃轻瘫患者的病程