Gastroparesis Clinical Research Consortium-University of Michigan Clinical Center

胃轻瘫临床研究联盟-密歇根大学临床中心

• 批准号: 8545801
• 负责人: WILLIAM L HASLER
• 金额: $ 11.28万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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/8545801
• 关键词: Abdominal Pain; Affect; Biopsy; Caring; Chronic; Clinical; Clinical Data; Clinical Research; Colon; Defect; Diagnosis; Disease; Distant; Enrollment; Etiology; Functional disorder; Gastric Emptying; Gastroparesis; Goals; Health; Insulin Infusion Systems; Intestines; Investigation; Knowledge; Learning; Maintenance; Malnutrition; Measures; Methods; Michigan; Motor; Multicenter Studies; Natural History; Nausea; Nausea and Vomiting; Nortriptyline; Nutritional Support; Obesity; Outcome; Pain; Pathogenesis; Pathology; Patients; Physicians; Pilot Projects; Placebos; Play; Quality of life; Questionnaires; Randomized; Recording of previous events; Recruitment Activity; Registries; Role; Safety; Satiation; Series; Severities; Site; Source; Stomach; Surveys; Symptoms; Techniques; Testing; Thick; Tissues; United States National Institutes of Health; Universities; Visit; Wireless Technology; aprepitant; base; capsule; cell motility; diabetic gastroparesis; double-blind placebo controlled trial; follow-up; gastrointestinal symptom; glucose monitor; improved; insight; knowledge base; laxative; motility disorder; novel; patient registry; placebo controlled study; randomized trial; response; safety study; therapy outcome; treatment response; treatment strategy; young woman

DESCRIPTION (provided by applicant): Gastroparesis is characterized by delayed gastric emptying in association with nausea, vomiting, fullness, early satiety, and pain that has devastating impacts on quality of life. Over 5 years, the Gastroparesis Clinical Research Consortium (GpCRC) has improved understanding of this disorder and advanced goals of patients, physicians, and the NIH for its care. Much still needs to be learned about its etiology, course, and therapy that serve as rationales to continue the consortium. This application has 3 specific aims. The first aim is to complete approved studies of the GpCRC including NORIG, a trial of nortriptyline vs. placebo for idiopathic gastroparesis (48 of 140 patients recruited to date), GLUMIT-DG, a study of the safety, feasibility, and potential efficacy of continuous glucose monitoring and insulin pump therapy in diabetic gastroparesis (2 of 40 recruited to date with 2 screened at Univ. of Michigan, APRON, a trial of aprepitant vs. placebo for nausea of presumed gastric origin (initiating 9/2010), and PBG, the pathological basis of gastroparesis (125 biopsies of 200 planned). The second aim is to maintain, expand, and refine the Gastroparesis Registry that enrolled 587 patients from 2/2007-3/2010. We will follow all patients for 4 years and some for 9 years. Informed by insight from the Registry, we propose recruiting more patients to answer new questions relating to pathogenesis, severity, complications, therapies, and outcomes of gastroparesis. The third aim will employ a novel wireless motility capsule (WMC) to characterize the role of generalized dysmotility in producing symptoms in patients with presumed gastroparesis. This study will define abnormal gastric, small intestinal and colonic transit and contractility and relate different motor defects to distinct symptom profiles of gastroparesis to give pathogenic insight relating to factors other than gastric emptying that cause different disease manifestations. The second part of the third aim will include a placebo-controlled trial of an osmotic laxative in patients with delayed gastric emptying and colon transit to test if treating distant dysmotilities improve a range of symptoms of gastroparesis. The studies of this application will significantly advance the knowledge base of the pathogenesis, clinical features, and management of this challenging disorder.

描述（由申请人提供）：胃轻瘫的特点是胃排空延迟，伴有恶心、呕吐、饱腹感、早饱感和疼痛，对生活质量产生毁灭性影响。五年来，胃轻瘫临床研究联盟 (GpCRC) 增进了对这种疾病的了解，并提高了患者、医生和 NIH 治疗该疾病的目标。关于其病因、病程和治疗方法仍需了解很多，以作为继续该联盟的理由。该应用程序有 3 个具体目标。第一个目标是完成已批准的 GpCRC 研究，包括 NORIG，一项去甲替林与安慰剂治疗特发性胃轻瘫的试验（迄今为止招募了 140 名患者中的 48 名），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、可行性和潜在疗效的研究（迄今为止招募的 40 名患者中的 2 名，其中 2 名在大学进行了筛选）。 密歇根州的 APRON，一项阿瑞匹坦与安慰剂治疗推测胃源性恶心的试验（2010 年 9 月开始），以及胃轻瘫的病理学基础 PBG（计划对 200 例进行 125 例活检）。第二个目标是维护、扩展和完善胃轻瘫登记处，该登记处于 2007 年 2 月至 2010 年 3 月期间登记了 587 名患者。我们将对所有患者进行 4 年跟踪，其中一些患者将跟踪 4 年 9年。根据登记处的见解，我们建议招募更多患者来回答与胃轻瘫的发病机制、严重程度、并发症、治疗和结果相关的新问题。第三个目标将采用一种新型无线运动胶囊（WMC）来表征全身运动障碍在疑似胃轻瘫患者产生症状中的作用。这项研究将定义胃异常、小 肠和结肠运输和收缩性，并将不同的运动缺陷与胃轻瘫的不同症状特征联系起来，以提供与胃排空以外导致不同疾病表现的因素相关的致病性见解。第三个目标的第二部分将包括对胃排空和结肠运输延迟的患者进行渗透性泻药的安慰剂对照试验，以测试治疗远处运动障碍是否可以改善一系列症状。 胃轻瘫。该应用的研究将显着推进这种具有挑战性的疾病的发病机制、临床特征和治疗的知识基础。