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: 8327160
• 负责人: WILLIAM L HASLER
• 金额: $ 15.55万
• 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/8327160
• 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）：胃轻瘫的特征是胃排空延迟，伴有恶心、呕吐、饱腹感、早期饱腹感和疼痛，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，并为患者、医生和NIH的护理制定了先进的目标。关于其病因、病程和治疗仍有许多需要了解的，这些都是继续联合治疗的依据。此应用程序有3个具体目标。第一个目标是完成GpCRC的批准研究，包括NORIG，一项去甲替林与安慰剂治疗特发性胃轻瘫的试验（迄今招募的140例患者中有48例），GLUMIT-DG，一项关于持续血糖监测和胰岛素泵治疗糖尿病性胃轻瘫的安全性、可行性和潜在疗效的研究（迄今招募的40例中有2例，其中2例在密歇根大学筛选），一项阿瑞吡坦与安慰剂治疗胃源性恶心的试验（开始于2010年9月），以及胃轻瘫的病理基础PBG（计划进行200例活检中的125例）。第二个目标是维持、扩大和完善胃轻瘫登记，该登记在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年甚至9年的随访。根据登记处的见解，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、治疗和结局的新问题。第三个目标将采用一种新型无线运动胶囊（WMC）来表征广泛性运动障碍在推定胃轻瘫患者产生症状中的作用。本研究将对胃、小肠和结肠的运输和收缩性异常进行定义，并将不同的运动缺陷与胃轻瘫的不同症状特征联系起来，以深入了解引起不同疾病表现的胃排空以外的因素。第三个目标的第二部分将包括一项安慰剂对照试验，在胃排空和结肠转运延迟的患者中使用渗透性泻药，以测试治疗远处运动障碍是否能改善胃轻瘫的一系列症状。这一应用的研究将显著提高对这一具有挑战性疾病的发病机制、临床特征和治疗的知识基础。