University of Louisville’s Clinical Center in Gastroparesis Clinical Research Consortium

路易斯维尔大学胃轻瘫临床研究联盟临床中心

• 批准号: 9235482
• 负责人: Thomas Lyman Abell
• 金额: $ 38.39万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 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 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9235482
• 关键词: Abdominal Pain; Affect; Anatomy; Ancillary Study; Area; Brain; Chronic; Clinical; Clinical Research; Complex; Data; Databases; Devices; Digestive System Disorders; Disease; Effectiveness; Electric Stimulation; Electrolytes; Enteral; Etiology; Functional disorder; Gastric Emptying; Gastroparesis; Goals; Grant; Health; Homeostasis; Inflammatory; Insulin Infusion Systems; Knowledge; Learning; Life; Liquid substance; Malnutrition; Measures; Methods; Mission; Motor; Motor Activity; Multicenter Studies; Natural History; Nausea; Nausea and Vomiting; Nortriptyline; Nutritional Support; Nutritional status; Outcome; Pain; Pathogenesis; Patient-Focused Outcomes; Patients; Peripheral; Physical Function; Physicians; Psychological Impact; Publications; Publishing; Quality of life; Recommendation; Recruitment Activity; Registries; Research; Safety; Sensory; Series; Severities; Signal Transduction; Stomach; Symptoms; Syndrome; Therapeutic; Time; Tissue Sample; United States National Institutes of Health; Universities; Visceral; Vomiting; Work; aprepitant; base; disability; early satiety; effective therapy; glucose monitor; improved; meetings; motor disorder; novel strategies; response; treatment strategy; young woman

Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying, frequently associated with chronic nausea and vomiting, early satiety, postprandial fullness, abdominal pain, and malnutrition that may require nutritional support. Gastroparesis has a devastating impact on quality of life and predominantly affects younger women. In the past 5 years, the Gastroparesis Clinical Research Consortium (GpCRC) has made a series of important contributions (see below) to improve our understanding of this disorder and advancing the goals of patients, physicians and the NIH for management of gastroparesis. Yet, much remains to be learned about its etiology, natural history, treatment strategies, and clinical course, which is the rationale behind our response to the Continuation of the Gastroparesis Consortium RFA-DK-10-502. The biggest barrier to effective therapeutic approaches to gastroparesis is our lack of knowledge about either its pathogenesis or its pathophysiology. Further, the correlation between the major symptoms such as nausea, vomiting, pain, and current methods to measure change in gastric function (electrical, motor activity, meal emptying times) is poor at best. Finally, we do not understand the long-term outcomes of these patients and whether outcomes differ on the basis of etiology, symptom severity, and degree of emptying abnormalities. Consequently, our approach to these patients is erratic and treatment has been empirical and only partially effective, if at all, in relieving the major symptoms. The mission of the GpCRC is completely aligned with the recommendations of the National Commission on Digestive Diseases;5 specifically, Research Goal 2.6 relates to gastroparesis and states: "Understand the noxious visceral signaling causing nausea and vomiting related to gastric neuro-electrical and/or motor dysfunction and the bi-directional brain-gut interactions. Gastroparesis provides an archetypal disease for investigative inquiry. Chronic vomiting, a debilitating and socially isolating digestive symptom, creates potentially life-threatening disruptions in fluid and electrolyte homeostasis and compromises nutritional status. Chronic nausea remains a significant hidden disability. Nausea and vomiting usually occur in tandem and overlay with other Gl symptoms as well as presenting in numerous digestive diseases. More effective treatments for nausea and vomiting would improve quality of life and physical functioning in a vast array of illnesses. A paucity of research exists for defining peripheral noxious signaling of nausea and vomiting related to primary Gl motor/sensory disturbances." The Specific Aims of this proposal are to: 1. Complete the current GpCRC registry; 2. To continue the GpCRC core lab, responsible for anatomic and related studies on tissue sample of patients with Gp syndromes; 3. Continue pharmacologic studies on patients with Gp syndromes; 4. Continue device studies for patients with the Gp syndromes; and 5. A new multicenter study, based on several GpCRC ancillary studies and other pilot data.

胃轻瘫是一种胃功能障碍，其特征是胃排空延迟，经常与胃排空障碍相关。 慢性恶心呕吐、早饱、餐后饱胀、腹痛和营养不良， 可能需要营养支持。胃轻瘫对生活质量有毁灭性的影响， 影响年轻女性。在过去的5年里，胃轻瘫临床研究联盟（GpCRC） 为提高我们对这种疾病的理解做出了一系列重要贡献（见下文）， 推进患者、医生和NIH管理胃轻瘫的目标。然而， 了解其病因，自然史，治疗策略和临床过程， 这是我们对胃轻瘫联盟RFA-DK-10-502的延续做出回应的依据。的 有效治疗胃轻瘫的最大障碍是我们缺乏对胃轻瘫的认识， 发病机理或其病理生理学。此外，恶心等主要症状之间的相关性， 呕吐、疼痛和当前测量胃功能变化的方法（电、运动活动、进食 清空时间）充其量是很差的。最后，我们不了解这些患者的长期结局， 结果是否因病因、症状严重程度和排空异常程度而不同。 因此，我们对这些患者的治疗方法是不稳定的，治疗是经验性的， 有效的，如果有的话，在减轻主要症状。GpCRC的使命完全符合 国家消化系统疾病委员会的建议;5具体而言，研究目标2.6涉及 胃轻瘫和国家：“了解有害的内脏信号导致恶心和呕吐有关， 胃神经电和/或运动功能障碍以及双向脑-肠相互作用。胃瘫 提供了一个典型的疾病调查。慢性呕吐，一种使人衰弱和社交孤立的 消化道症状，造成潜在的危及生命的破坏液体和电解质稳态， 会影响营养状况慢性恶心仍然是一种重要的隐性残疾。恶心和呕吐 通常与其他胃肠道症状同时发生，并在许多消化道疾病中出现。 疾病更有效的治疗恶心和呕吐将改善生活质量和身体健康。 在各种疾病中发挥作用。缺乏研究存在定义外周有害信号， 与原发性胃肠道运动/感觉障碍相关的恶心和呕吐。" 本提案的具体目标是：1.完成当前GpCRC注册; 2.继续GpCRC 核心实验室，负责GP综合征患者组织标本的解剖学及相关研究; 继续对GP综合征患者进行药理学研究; 4.继续对患者进行器械研究， GP综合征;和5.一项新的多中心研究，基于几项GpCRC辅助研究和其他初步研究 数据