Temple University Gastroparesis Clinical Center

天普大学胃轻瘫临床中心

• 批准号: 8327158
• 负责人: HENRY PAUL PARKMAN
• 金额: $ 36.53万
• 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 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8327158
• 关键词: Abdominal Pain; Affect; Biopsy; Chronic; Clinical; Clinical Data; Clinical Research; Diagnosis; Disease; Distal; Enrollment; Etiology; Evaluation; Functional disorder; Gastric Emptying; Gastroparesis; Goals; Hour; Insulin Infusion Systems; Learning; Maintenance; Malnutrition; Measures; Multicenter Studies; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Nausea; Nausea and Vomiting; Nortriptyline; Nutritional Support; Obesity; Outcome; Pathogenesis; Pathology; Patients; Physicians; Pilot Projects; Placebos; Principal Investigator; Qualifying; Quality of life; Questionnaires; Radionuclide Imaging; Recruitment Activity; Registries; Reproducibility; Research; Safety; Satiation; Series; Severities; Stomach; Symptoms; Testing; Thick; Tissues; United States National Institutes of Health; Universities; Visit; Wireless Technology; aprepitant; base; capsule; cell motility; diabetic gastroparesis; effective therapy; follow-up; gastrointestinal symptom; glucose monitor; improved; insight; motility disorder; patient registry; programs; randomized trial; response; treatment response; treatment strategy; young woman

DESCRIPTION (provided by applicant): Patients with gastroparesis often suffer with chronic gastrointestinal symptoms that are not adequately treated due to both a lack of understanding of the underlying pathophysiology and lack of effective treatments. The participation of Temple University 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. The PI and Temple University are exceptionally well qualified to continue to be one of the clinical centers in this consortium. Temple University has clinical expertise and an active research program in the evaluation and treatment of patients with gastroparesis. The aims for this renewal of the Gastroparesis Consortium are threefold. First, to complete the ongoing and approved studies initiated by the GpCRC. These studies include NORIG: a randomized trial of nortriptyline vs. placebo for idiopathic gastroparesis; GLUMIT-DG: a pilot study of safety, feasibility and potential efficacy of continuous glucose monitoring and insulin pump therapy in diabetic gastroparesis; APRON: a randomized trial of aprepitant vs. placebo for the relief of nausea in patients with chronic nausea and vomiting of presumed gastric origin; PBG: pathological basis of gastroparesis, a tissue study from full thickness gastric biopsies. Second, to maintain and expand the Gastroparesis Registry. Our aim is to have at least four years of follow-up on patients and with up to nine years for some patients. This will require maintenance of the Registry and continued periodic follow-up visits over the next five years. In addition, we propose recruitment of new patients during continuation of the Gastroparesis Consortium with refinements to existing questionnaires and pathophysiologic measures, as well as new ones. This will allow us to answer questions related to the pathogenesis, severity grading, complications, treatment responses, and clinical outcomes in patients with gastroparesis. Third, to conduct new multicenter studies of gastroparesis investigating the etiology, pathogenesis, diagnosis, and treatment. The PI with his collaborators at Temple University propose a multicenter study aimed at improving the diagnosis of gastric motility disorders. The overall purpose of this project is to develop a single more comprehensive noninvasive test which evaluates several components of gastric motility and, thus, may improve the correlation between dyspeptic symptoms and gastric dysmotility. This will ultimately enable physicians to better target therapy to the underlying gastric pathophysiologic abnormality in 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，由于缺乏对潜在病理生理学的了解和缺乏有效的治疗，这些症状没有得到充分治疗。天普大学参与 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。 PI 和坦普尔大学非常有资格继续成为该联盟的临床中心之一。天普大学在胃轻瘫患者的评估和治疗方面拥有临床专业知识和活跃的研究项目。胃轻瘫联盟的这次更新有三个目标。首先，完成 GpCRC 发起的正在进行且已批准的研究。这些研究包括 NORIG：去甲替林与安慰剂治疗特发性胃轻瘫的随机试验； GLUMIT-DG：一项关于连续血糖监测和胰岛素泵治疗糖尿病胃轻瘫的安全性、可行性和潜在功效的初步研究； APRON：一项阿瑞匹坦与安慰剂对比缓解疑似胃源性慢性恶心和呕吐患者恶心的随机试验； PBG：胃轻瘫的病理基础，来自全层胃活检的组织研究。其次，维持和扩大胃轻瘫登记处。我们的目标是对患者进行至少四年的随访，对某些患者进行长达九年的随访。这将需要在未来五年内维护登记处并持续定期进行后续访问。此外，我们建议在胃轻瘫联盟继续开展期间招募新患者，并对现有问卷和病理生理学措施以及新的问卷和病理生理学措施进行改进。这将使我们能够回答与胃轻瘫患者的发病机制、严重程度分级、并发症、治疗反应和临床结果相关的问题。第三，开展新的胃轻瘫多中心研究，探讨胃轻瘫的病因、发病机制、诊断和治疗。该 PI 与天普大学的合作者提出了一项多中心研究，旨在改善胃动力障碍的诊断。该项目的总体目的是开发一种更全面的无创测试，评估胃动力的多个组成部分，从而可以改善消化不良症状与胃动力障碍之间的相关性。这最终将使医生能够更好地针对胃轻瘫患者潜在的胃病理生理异常进行针对性治疗。