Advancing Science for the Diagnosis and Treatment of Gastroparesis

描述（由申请人提供）：胃轻瘫是一种胃功能障碍，其特征是胃排空延迟，经常伴有慢性恶心和呕吐，早饱，餐后饱腹感，腹痛和可能需要营养支持的营养不良。本提案的广泛目标是提高我们对这种疾病的理解，推进胃轻瘫及相关疾病的诊断和治疗。具体目标1：完成由美国国立卫生研究院资助的GpCRC（胃轻瘫临床研究联盟，由六个临床站点和数据协调中心合作）发起的正在进行和已批准的研究。这些研究包括(1)去甲替林与安慰剂治疗特发性胃轻瘫的随机试验，(2)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初步研究，(3)阿瑞吡坦与安慰剂缓解慢性恶心和呕吐患者的恶心的随机试验，以及(4)全层胃活检的组织研究。具体目标2：维护、扩展和完善胃轻瘫注册（ClinicalTrials.gov NCT00398801），以便对临床数据和生物样本进行关键的附加分析。2007年2月招募了第一位胃轻瘫患者，到2010年3月招募结束时共招募了587名患者。我们的目标是对所有患者进行至少4年的随访，对一些患者进行长达9年的随访。这将需要维持书记官处，并在今后五年内继续定期进行后续访问。特定目的3：了解胃轻瘫和慢性不明原因恶心呕吐患者胃感觉运动功能的氮能控制：与性别、糖尿病和胃排空表型的相关性。

DESCRIPTION (provided by applicant): Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying, frequentiy associated with chronic nausea and vomiting, eariy satiety, postprandial fullness, abdominal pain, and malnutrition that may require nutritional support. The broad objectives of this proposal is to improve our understanding ofthls disorder and advancing the diagnosis and treatment of gastroparesis and related disorders. We propose to do this through three specific aims, as follows: Specific Aim 1: To complete ongoing and approved studies initiated by the NIH-funded GpCRC (the Gastroparesis Clinical Research Consortium, a collaboration between six clinical sites and data coordinating center). These include (1) a randomized trial of nortriptyline vs. placebo for idiopathic gastroparesis, (2) a pilot study of safety, feasibility and potential efficacy of continuous glucose monitoring and insulin pump therapy in diabetic gastroparesis, (3) a randomized trial of aprepitant vs. placebo for the relief of nausea in patients with chronic nausea and vomiting of presumed gastric origin and (4) a tissue study from full thickness gastric biopsies. Specific Aim 2: To maintain, expand, and refine the Gastroparesis Registry (ClinicalTrials.gov NCT00398801) in order to enable critical additional analyses of the clinical data and biosamples. The first Registry patient with gastroparesis was recruited in February 2007 and a total of 587 patients were enrolled by end of recruitment in March 2010. Our aim is to have at least four years of follow-up on all patients and with up to 9 years for some patients. This will require maintenance of the Registry and continued periodic follow-up visits over the next five years. Specific Aim 3: To understand nitrergic control of gastric sensorimotor function: correlation with gender, diabetes and gastric emptying phenotype in patients with gastroparesis and chronic unexplained nausea and vomiting.