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

在 NIDDK 的 Gastropa 建立 UMMC 临床中心*

• 批准号: 7497375
• 负责人: Thomas Lyman Abell
• 金额: $ 0.98万
• 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/7497375
• 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

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.

密西西比大学医学中心建议作为临床中心参与NIDDK的胃轻瘫 临床研究联盟。我们的研究团队由医学博士托马斯阿贝尔领导，他有着悠久的研究历史， 胃轻瘫领域的临床经验。团队成员包括几位主要的研究人员， 阿贝尔曾在过去和谁合作，共同提供了一个有价值的多学科方法，胃轻瘫 research. 该应用程序的一个主要优势是UMMC提供的潜在研究人群。我们目前正在跟踪 大约1,000名胃轻瘫患者。在过去的41个月里，我们评估了550名新患者， 胃轻瘫;因此平均每年有160名新患者。 UMMC强烈支持在校园内建立临床中心。医学中心副校长 负责卫生事务的副校长和负责研究的副校长承诺提供必要的资源 进行联合体的研究。 已经提出了两个协议。第一项研究旨在验证胃轻瘫患者 一个或多个重叠综合征比没有外周多巴胺受体阻滞剂的患者更可能对外周多巴胺受体阻滞剂有反应。 重叠综合征该提案的具体目标是：（1）收集和记录有关每个国家的重要信息， 研究参与者;（2）通过24小时霍尔特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） 比较有和没有重叠综合征的研究参与者对药理学干预的反应; 和. (5)比较血清学自身免疫异常的研究参与者对药物治疗的反应， 干预 第二项研究旨在检验固体胃排空延迟的患者将有更好的 症状反应临时胃电刺激（GES）比那些谁是非延迟。具体目标 该建议是：（1）为联盟的其他临床中心提供内窥镜放置方面的培训， 临时GES;（2）对临时GES进行全联盟随机双盲临床试验;（3）比较 在基线时和使用临时GES后的某些标志物;（4）确定基线参数中的两个， 皮肤EGG值和粘膜EGG值，可以预测对GES的反应;和（5）根据结果， 研究，制定指导方针，以更好地确定谁最有可能受益于永久GES。