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）：胃轻瘫的患者通常患有慢性胃肠道症状，由于对潜在的病理生理学缺乏了解和缺乏有效治疗的了解，这些胃肠道症状没有得到充分治疗。坦普尔大学（Temple University）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。 PI和Temple University非常有资格继续成为该财团的临床中心之一。坦普尔大学拥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。胃癌联盟续约的目的是三倍。首先，要完成GPCRC发起的正在进行的和批准的研究。这些研究包括Norig：一项诺特林林与安慰剂的随机试验，用于特发性胃轻瘫； Glumit-DG：一项针对糖尿病性胃癌中连续葡萄糖监测和胰岛素泵治疗的安全性，可行性和潜在疗效的试点研究；围裙：对慢性恶心和假定胃起源呕吐患者的恶心的随机试验与安慰剂缓解恶心； PBG：胃轻瘫的病理基础，这是一项来自胃胃活检的组织研究。其次，维持和扩展胃清洗注册中心。我们的目的是对患者进行至少四年的随访，并且有些患者最多需要9年。这将需要在未来五年内维护注册表并继续定期随访。此外，我们建议在继续胃肉联盟期间招募新患者，并对现有的问卷和病理生理措施以及新患者进行改进。这将使我们能够回答与胃轻瘫患者的发病机理，严重程度分级，并发症，治疗反应和临床结局有关的问题。第三，对研究病因，发病机理，诊断和治疗进行新的多中心研究。 PI与他在Temple University的合作者提出了一项多中心研究，旨在改善胃运动障碍的诊断。该项目的总体目的是开发一个更全面的非侵入性测试，该测试评估了胃运动的几个组成部分，因此可以改善消化不良症状与胃不良功能障碍之间的相关性。这最终将使医生能够更好地靶向胃轻瘫患者的潜在胃病理生理异常。