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: 7902098
• 负责人: Neera Gupta
• 金额: $ 12.57万
• 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/7902098
• 关键词: Accounting; Adverse effects; Affect; Age; Applications Grants; Arts; Award; Biostatistical Methods; 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; K-Series Research Career Programs; Length; Letters; Linear Regressions; Longitudinal Studies; Measurement; Measures; Medical; Medical center; Mentored Patient-Oriented Research Career Development Award; Mentors; Methodology; Methods; Modeling; Multivariate Analysis; Nature; Newly Diagnosed; Normal Range; Nurse Practitioners; Outcome Measure; Parents; Pathogenesis; Patient Care; Patients; Pharmaceutical Preparations; Physiological; Pilot Projects; Principal Investigator; Procedures; Production; Prospective Studies; Protocols documentation; 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; 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 age; career; career development; cohort; cytokine; effective intervention; energy balance; experience; hormone resistance; hormone sensitivity; illness length; improved; indexing; interest; male; patient oriented; prevent; programs; psychosocial; public health relevance; relational database; 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）： 这是一份K23奖的申请书，申请人是加州大学旧金山弗朗西斯科的儿科胃肠病学家Neera Gupta博士。Gupta博士正在建立自己作为一个年轻的研究者在儿童炎症性肠病（IBD）的患者为导向的临床研究。该K23奖项将为Gupta博士提供必要的支持，以实现以下目标：（1）成为以患者为导向的儿童IBD临床研究专家;（2）对IBD儿童患者的生长进行内分泌方面的临床研究;（3）在临床研究中实施先进的生物统计方法;（4）在临床研究中实施生物统计学方法。（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生涯。为了实现这些目标，Gupta博士组建了一个指导团队，由一位主要导师Melvin Heyman博士和三位共同导师组成，Melvin Heyman博士是加州大学旧金山分校儿科胃肠病学培训项目主任，他在儿科IBD中进行临床研究，Robert Lustig博士是一位内分泌学家，专注于下丘脑功能及其对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专家; Michael Kohn博士，具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公认的并发症。Gupta博士的研究将集中在性别和年龄在疾病表现和诊断对身高和生长速度z评分的相对影响，在新诊断的克罗恩病儿科患者（目的1）和性别的相对影响，青春期发育（坦纳分期）和疾病活动性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评分的影响（目的2）.在目标1中，Gupta博士将利用儿科IBD联盟（由6个地理位置不同的美国地区的中心组成）的现有基础设施，招募并随访200名新诊断的克罗恩病儿科患者，以确定疾病表现和诊断时性别和年龄对生长的独立影响。在目标2中，Gupta博士将进行一项单中心横断面试点研究，以生成有关性别、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。这两项研究都将采用先进的多元统计方法。这项研究将为新诊断的儿童克罗恩病的多中心纵向研究奠定基础，该研究将在K奖结束前在R 01资助申请中提出。 公共卫生相关性：进一步了解克罗恩病患儿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过程中性别差异的潜在机制。