Gender Differences in Growth in Pediatric Patients with Crohn's Disease

克罗恩病儿科患者生长的性别差异

• 批准号: 7418701
• 负责人: Neera Gupta
• 金额: $ 12.44万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7418701
• 关键词: Accounting; Adverse effects; Affect; Age; Applications Grants; Arts; Award; Biostatistical Methods; Bone Development; California; Child; Childhood; Chronic Disease; Clinic; Clinical Management; Clinical Research; Clinical Trials; Complication; Crohn' s disease; Data; Data Collection; Databases; Development; Diagnosis; Dietary intake; Disease; Endocrinologist; Enrollment; Ensure; Estrogens; Etiology; Exhibits; Failure; Family; Female; Funding; Future; Gastroenterologist; Gastroenterology; Gender; Goals; Growth; Growth and Development function; Height; Hepatic; Hypothalamic structure; Impairment; Incidence; Individual; Inflammation; Inflammatory; Inflammatory Bowel Diseases; Institution; Insulin-Like Growth Factor I; Intervention; K-Series Research Career Programs; Length; Letters; Longitudinal Studies; Measurement; Measures; Medical; Medical center; Mentored Clinical Oncology Award; Mentored Clinical Scientist Award; Mentored Patient-Oriented Research Career Development Award; Mentors; Methodology; Methods; Modeling; Multivariate Analysis; Nature; Newly Diagnosed; Normal Range; Numbers; Nurse Practitioners; Outcome Measure; Parents; Pathogenesis; Patient Care; Patients; Pharmaceutical Preparations; Physiological; Pilot Projects; Principal Investigator; Procedures; Production; Prospective Studies; Protocols documentation; Public Health; Quality of life; Registries; Regression Analysis; Regulation; Relative (related person); Research; Research Design; Research Infrastructure; Research Personnel; Resources; Retrospective Studies; Risk; Risk Factors; San Francisco; Score; Serum; Severities; Severity of illness; Sex Characteristics; Site; Somatotropin; Staging; Statistical Methods; Statistical Models; Techniques; Testing; Testosterone; Texas; Time; Training Programs; Tumor Necrosis Factor-alpha; Universities; Weight; Writing; age effect; base; bone; career; cohort; cytokine; energy balance; experience; hormone resistance; hormone sensitivity; illness length; improved; indexing; interest; male; patient oriented; prevent; programs; psychosocial; skills; success; urinary

DESCRIPTION (provided by applicant): This is an application for a K23 award for Dr. Neera Gupta, a pediatric gastroenterologist at the University of California, San Francisco. Dr. Gupta is establishing herself as a young investigator in patient-oriented clinical research of pediatric inflammatory bowel disease (IBD). This K23 award will provide Dr. Gupta with the support necessary to accomplish the following goals: (1) to become expert at patient-oriented clinical research in pediatric IBD; (2) to conduct clinical investigations of endocrinologic aspects of growth in pediatric patients with IBD; (3) to implement advanced biostatistical methods in clinical studies; (4) to develop and maintain a relational database containing data from multiple sites; and (5) to develop an independent clinical research career. To achieve these goals, Dr. Gupta has assembled a mentoring team comprised of a primary mentor, Dr. Melvin Heyman, Director of the Training Program in Pediatric Gastroenterology at UCSF, who conducts clinical investigations in pediatric IBD, and three co-mentors: Dr. Robert Lustig, an endocrinologist who focuses on hypothalamic function and its regulation of growth and energy balance; Dr. Eric Vittinghoff, an expert in study design and current state-of-the-art biostatistical methods; and Dr. Michael Kohn, who has expertise in database development and management. Growth impairment is a well-recognized complication of Crohn's disease. Dr. Gupta's research will focus on the relative influence of gender and age at disease presentation and diagnosis on height and growth velocity z scores in newly diagnosed pediatric patients with Crohn's disease (Aim 1) and the relative effects of gender, pubertal development (Tanner stage) and disease activity on growth hormone/insulin-like growth factor I levels and height z scores in pediatric patients with Crohn's disease (Aim 2). In Aim 1, Dr. Gupta will use the existing infrastructure of the Pediatric IBD Consortium (composed of centers in 6 geographically distinct US regions) to enroll and follow 200 newly-diagnosed pediatric patients with Crohn's disease to determine the independent effects of gender and age at disease presentation and diagnosis on growth. In Aim 2, Dr. Gupta will conduct a single-center cross-sectional pilot study to generate preliminary data on the effects of gender, pubertal status, and disease severity on growth in children with Crohn's disease. Both studies will utilize advanced multivariate statistical methods. This research will form the basis for a multicenter longitudinal study in newly diagnosed childhood Crohn's disease, to be proposed in an R01 grant application before the end of the K award. Public health relevance: Improved understanding of the etiology and gender-associated differences in growth impairment in pediatric patients with Crohn's disease is critical to determine effective medical management strategies and may clarify the underlying mechanisms for gender differences in the course of this chronic disorder.

描述（由申请人提供）： 这是加州大学旧金山分校儿科胃肠病学家 Neera Gupta 博士的 K23 奖项申请。 Gupta 博士正在将自己打造成以患者为导向的小儿炎症性肠病 (IBD) 临床研究领域的年轻研究者。该 K23 奖项将为 Gupta 博士提供实现以下目标所需的支持：（1）成为以患者为导向的儿科 IBD 临床研究专家； (2) 对 IBD 儿科患者生长的内分泌方面进行临床研究； （3）在临床研究中实施先进的生物统计学方法； (4) 开发和维护包含多个站点数据的关系数据库； (5)发展独立的临床研究事业。为了实现这些目标，Gupta 博士组建了一个指导团队，由一名主要导师 Melvin Heyman 博士（加州大学旧金山分校儿科胃肠病学培训项目主任，负责儿科 IBD 的临床研究）和三名联合导师组成：Robert Lustig 博士，内分泌学家，专注于下丘脑功能及其生长和能量平衡的调节； Eric Vittinghoff 博士，研究设计和当前最先进的生物统计方法方面的专家； Michael Kohn 博士拥有数据库开发和管理方面的专业知识。 生长障碍是克罗恩病众所周知的并发症。 Gupta 博士的研究将重点关注疾病表现和诊断时的性别和年龄对新诊断克罗恩病儿科患者身高和生长速度 z 得分的相对影响（目标 1），以及性别、青春期发育（Tanner 阶段）和疾病活动对克罗恩病儿科患者生长激素/胰岛素样生长因子 I 水平和身高 z 得分的相对影响（目标 2）。在目标 1 中，Gupta 博士将利用儿科 IBD 联盟（由美国 6 个不同地理区域的中心组成）的现有基础设施来招募和跟踪 200 名新诊断的克罗恩病儿科患者，以确定性别和年龄在疾病表现和诊断时对生长的独立影响。在目标 2 中，Gupta 博士将进行一项单中心横断面试点研究，以生成关于性别、青春期状态和疾病严重程度对克罗恩病儿童生长影响的初步数据。这两项研究都将利用先进的多元统计方法。这项研究将构成针对新诊断的儿童克罗恩病的多中心纵向研究的基础，该研究将在 K 奖结束之前在 R01 拨款申请中提出。 公共卫生相关性：更好地了解克罗恩病儿科患者生长障碍的病因和性别相关差异对于确定有效的医疗管理策略至关重要，并可能阐明这种慢性疾病病程中性别差异的潜在机制。