Establishing UMMC's Clinical Center in NIDDK's Gastroparesis Research Consortium

在 NIDDK 胃轻瘫研究联盟中建立 UMMC 临床中心

• 批准号: 7430400
• 负责人: Thomas Lyman Abell
• 金额: $ 34.13万
• 依托单位: UNIVERSITY OF MISSISSIPPI MED CTR
• 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 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7430400
• 关键词: Address; Adverse effects; African American; Area; Autoimmune Process; Cell physiology; Characteristics; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials; Commit; Cutaneous; Detection; Devices; Diagnosis; Disease; Domperidone; Dopamine; Double-Blind Method; Effectiveness; Electric Stimulation; Electrodes; Electrophysiology (science); Enteral; Enteric Nervous System; Female; Fibromyalgia; Frequencies; Functional disorder; Gastric Emptying; Gastroparesis; Generic Drugs; Goals; Guidelines; Head; Health; Heart Rate; Hispanics; Holter Electrocardiography; Hour; Implant; Implanted Electrodes; Incidence; Individual; Interstitial Cystitis; Intervention; Knowledge; Length; Letters; Location; Long-Term Effects; Measures; Medical center; Metoclopramide; Migraine; Mississippi; Modeling; Myenteric Plexus; National Institute of Diabetes and Digestive and Kidney Diseases; Native Americans; Nervous system structure; Neurologic; Numbers; Operative Surgical Procedures; Oral; Orphan Drugs; Outpatients; Parkinsonian Disorders; Participant; Patients; Peripheral; Pharmaceutical Preparations; Placebos; Placement; Play; Population Study; Prevalence; Principal Investigator; Protocols documentation; Quality of life; Randomized; Recording of previous events; Refractory; Reporting; Research; Research Design; Research Personnel; Resources; Role; Serological; Silver; Social Problems; Solid; Spectrum Analysis; Stomach; Submucous Plexus; Surface; Surveys; Symptoms; Syndrome; Testing; Time; Training; Universities; Week; Work; base; day; design; diabetic; endometriosis; experience; gastrointestinal function; implantation; improved; interdisciplinary approach; interstitial; member; nervous system disorder; programs; response; week trial

DESCRIPTION (provided by applicant): 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

描述（由申请人提供）： 密西西比大学医学中心提议作为临床中心参与 NIDDK 胃轻瘫临床研究联盟。我们的研究团队由医学博士 Thomas Abell 领导，他在胃轻瘫领域拥有悠久的研究历史和临床经验。团队成员包括几位领先的研究人员，Abell 博士过去曾与他们合作过，他们共同为胃轻瘫研究提供了有价值的多学科方法。 该应用程序的主要优势是 UMMC 提供的潜在研究人群。我们目前正在追踪大约 1,000 名胃轻瘫患者。在过去 41 个月中，我们对 550 名新患者进行了胃轻瘫评估；因此平均每年有 160 名新患者。 UMMC 大力支持在其校园内建立临床中心。医学中心负责健康事务的副校长和负责研究的副校长已承诺提供开展联盟研究所需的资源。 已经提出了两个协议。第一项研究旨在检验以下假设：患有一种或多种重叠综合征的胃轻瘫患者比没有重叠综合征的患者更有可能对外周多巴胺阻滞剂产生反应。该提案的具体目标是：（1）收集并记录每个研究参与者的重要信息； (2) 通过 24 小时动态心电图监测心率变异性，记录研究参与者的基线自主神经状态； (3) 为研究参与者提供外周多巴胺阻滞剂多潘立酮的试用； (4) 比较患有和不患有重叠综合征的研究参与者对药物干预的反应； (5) 比较具有血清学自身免疫异常的研究参与者对药物干预的反应。 第二项研究旨在检验这样的假设：固体胃排空延迟的患者对临时胃电刺激（GES）的症状反应比非延迟的患者更好。该提案的具体目标是： (1) 向联盟的其他临床中心提供临时 GES 内窥镜放置方面的培训； (2) 开展全联盟范围的随机、双盲临时GES临床试验； (3) 比较基线时和使用临时 GES 后的某些标志物； (4)确定两个基线参数，皮肤EGG值和粘膜EGG值是否可以预测对GES的反应； (5) 根据研究结果，制定指南，以更好地识别那些最有可能从永久性 GES 中受益的人