Establishing UMMC's Clinical Center in NIDDK's Gastropa*

密西西比大学医学中心提议作为临床中心参与NIDDK的胃瘫 临床研究联盟。我们的研究团队由托马斯·阿贝尔博士领导，他有很长的研究历史和 胃轻瘫的临床经验。团队成员包括几位顶尖的研究人员。 Abell过去曾合作过，他们共同为胃瘫提供了一种有价值的多学科方法 研究。 这一应用的一个主要优势是UMMC必须提供的潜在研究人群。我们目前正在关注 大约1000名胃瘫患者。在过去的41个月里，我们对550名新患者进行了评估 胃瘫；因此，平均每年有160名新患者。 UMMC强烈支持在其校园内建立临床中心。医疗中心的副校长 负责卫生事务的副校长和负责研究的协理副校长承诺提供必要的资源 进行财团的研究。 已经提出了两个协议。第一项研究旨在检验胃轻瘫患者是否患有 一个或多个重叠综合征比没有外周多巴胺阻滞剂的患者更有可能对外周多巴胺阻滞剂有反应 重叠综合征。这项建议的具体目标是：(1)收集和记录关于每个 研究参与者；(2)通过24小时动态心电图监测记录研究参与者的基线自主神经状态 心率变异性；(3)为研究参与者提供外周多巴胺阻滞剂多潘立酮的试验；(4) 比较有重叠综合征和无重叠综合征的研究参与者对药物干预的反应； 和(5)比较有血清学自身免疫异常的研究参与者对药物的反应。 干预。 第二项研究旨在检验这样一种假设，即固体胃排空延迟的患者将有更好的 对暂时性胃电刺激(GES)的症状反应优于非延迟性胃电刺激(GES)。具体目标为 这项提议是：(1)向财团的其他临床中心提供内窥镜放置方面的培训 临时GES；(2)进行全联盟范围的临时GES随机双盲临床试验；(3)比较 在基线上和在使用临时GES之后的某些标记；(4)确定基线参数中的两个， 皮肤卵子值和粘膜卵子值可以预测对GES的反应；以及(5)基于 研究，制定指导方针，以更好地确定哪些人最有可能受益于永久性全球经济共同体。

The University of Mississippi Medical Center proposes to participate as a Clinical Center in NIDDK's Gastroparesis Clinical Research Consortium. Our study team is headed by Thomas Abell, MD, who has a long history of research and clinical experience in the area of gastroparesis. Team members include several leading researchers with whom Dr. Abell has collaborated in the past and who, together, provide a valuable multidisciplinary approach to gastroparesis research. A major strength of this application is the potential study population that UMMC has to offer. We are currently following approximately 1,000 patients with gastroparesis. During the past 41 months, we have evaluated 550 new patients for gastroparesis; thus averaging 160 new patients per year. UMMC strongly supports the establishment of a Clinical Center on its campus. The Medical Center's Vice Chancellor for Health Affairs and the Associate Vice Chancellor for Research have committed to providing the resources necessary to conduct the research of the Consortium. Two protocols have been proposed. The first study is designed to test the hypothesis that gastroparesis patients with one or more overlap syndromes are more likely to respond to a peripheral dopamine blocker than patients without overlap syndromes. Specific aims for this proposal are to: (1) collect and record important information about each of the study participants; (2) document study participants' baseline autonomic status through 24-hour holter monitoring of heart rate variability; (3) provide study participants with a trial of the peripheral dopamine blocker, domperidone; (4) compare the response of study participants with and without overlap syndromes to the phamacologic intervention; and.(5) compare the response of study participants with serologic autoimmune abnormalities to the phamacologic intervention. The second study is designed to test the hypothesis that patients with delayed solid gastric emptying will have better symptom response to temporary gastric electrical stimulation (GES) than those who are non-delayed. Specific aims for this proposal are to: (1) provide training to the Consortium's other clinical centers in the endoscopic placement of temporary GES; (2) conduct a consortium-wide randomized, double-blind clinical trial of temporary GES; (3) compare certain markers at baseline and after the use of temporary GES; (4) determine whether two of the baseline parameters, cutaneous EGG values and mucosal EGG values, can predict response to GES; and (5) based on the results of the study, develop guidelines to better identify those who would most likely benefit from permanent GES.