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: 8730615
• 负责人: WILLIAM L HASLER
• 金额: $ 11.76万
• 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/8730615
• 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（由申请方提供）：胃轻瘫的特征是胃排空延迟，伴有恶心、呕吐、饱胀、早饱和疼痛，对生活质量有破坏性影响。5年来，胃轻瘫临床研究联盟（GpCRC）提高了对这种疾病的理解，并提高了患者，医生和NIH对其护理的目标。关于其病因、病程和治疗仍有许多需要了解的地方，这些都是继续该联盟的基础。该应用程序有三个具体目标。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（迄今为止招募的140例患者中的48例），GLUMIT-DG，一项关于糖尿病胃轻瘫患者连续血糖监测和胰岛素泵治疗的安全性、可行性和潜在疗效的研究（迄今为止招募的40例患者中有2例，其中2例在密歇根大学、APRON（一项关于阿瑞匹坦与安慰剂治疗假定胃源性恶心的试验，2010年9月开始）和PBG（胃轻瘫的病理基础）进行筛选（计划200例患者中有125例活检）。第二个目标是维持、扩展和完善胃轻瘫登记研究，该研究从2007年2月至2010年3月招募了587例患者。我们将随访所有患者4年，部分患者随访9年。从登记处的见解，我们建议招募更多的患者来回答有关胃轻瘫的发病机制，严重程度，并发症，治疗和结果的新问题。第三个目标将采用一种新型的无线动力胶囊（WMC）来表征全身性运动障碍在推定胃轻瘫患者中产生症状的作用。本研究将定义胃、小肠和结肠传输和收缩力异常，并将不同的运动缺陷与胃轻瘫的不同症状特征相关联，以提供与引起不同疾病表现的胃排空以外因素相关的致病性见解。第三个目标的第二部分将包括一项安慰剂对照试验，在胃排空延迟和结肠运输延迟的患者中使用渗透性泻药，以测试治疗远端运动障碍是否能改善胃轻瘫的一系列症状。这项应用的研究将显着推进知识基础的发病机制，临床特点，和管理这一具有挑战性的疾病。