儿科 2 型糖尿病治疗统计中心-猫眼课题宝

儿科 2 型糖尿病治疗统计中心

批准号：

7497286

负责人：

KATHRYN HIRST

金额：

$22.63万

依托单位：

GEORGE WASHINGTON UNIVERSITY

依托单位国家：

美国

项目类别：

财政年份：

2001

资助国家：

美国

项目状态：

已结题

起止时间：

2001-09-30 至 2009-02-28

来源：

https://reporter.nih.gov/project-details/7497286

关键词：

Accident and Emergency department Address Adolescent Adult Advisory Committees Affect African American American Amniocentesis Angioplasty Appendix Asians Balloon Angioplasty Belief Biometry Body Composition Breathing Bypass Caring Case-Control Studies Child Childhood Church Clinic Clinical Clinical Investigator Clinical Research Clinical Treatment Clinical Trials Clinical Trials Data Monitoring Committees Closure Collaborations Computers Condition Conduct Clinical Trials Consultations Coronary County Credentialing Data Data Analyses Data Collection Data Coordinating Center Data Quality Databases Dedications Detection Development Diabetes Mellitus Diagnosis Dietary Fats Dietary Fiber Discipline of obstetrics Disease Disease Progression Doctor of Philosophy Dropout Drug Kinetics Educational Curriculum Educational Intervention Endocrine Endocrinology Enrollment Ensure Environmental Risk Factor Epidemiologic Studies Estradiol Estrogens Family member Foundations Funding Grant Head Health Health Educators Health education Health system Healthcare Hispanics Hormonal Change Hospitalization Infusion Pumps Infusion procedures Insulin Insulin Resistance Insulin-Dependent Diabetes Mellitus Intake Internal Medicine Internet Intervention Investigation Journals Knowledge Lead Lesion Manuals Manuscripts Measures Medical Medicine Metabolic Metabolic Control Metformin Methods Minority Monitor Multi-Institutional Clinical Trial National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases Native Americans Natural History New England New Jersey Non-Insulin-Dependent Diabetes Mellitus Numbers Nursing Administration Research Obesity Operative Surgical Procedures Osteoporosis prevention Out-Migrations Outcome Pacific Island Americans Paper Participant Patients Pediatrics Performance Personal Satisfaction Pharmaceutical Preparations Pharmacology Phase Pilot Projects Pioglitazone Placebos Plants Population Postmenopause Prenatal Diagnosis Prevention Prevention intervention Primary Prevention Principal Investigator Procedures Protocols documentation Provider Puberty Publications Publishing Pulmonary Embolism Randomized Recommendation Reporting Research Research Infrastructure Research Personnel Research Project Grants Resources Rheumatoid Arthritis Risk Reduction Role Safety Sampling Sarcoidosis Science Screening procedure Secure Series Siblings Site Stents Stimulus Susceptibility Gene System Techniques Technology Testing Treatment Efficacy Turner&apos s Syndrome U-Series Cooperative Agreements United States National Institutes of Health Universities Upper arm Vascular Diseases Villus Visit Washington Week Woman Women&apos s Health Work Workplace Writing Youth base data management design diabetes education diabetes mellitus therapy diabetes prevention program experience fetal genetic analysis glucose monitor glycemic control impaired glucose tolerance improved interest lifestyle intervention member metabolic abnormality assessment nutrition older women outreach patient safety pediatric pharmacology professor programs prospective protocol development repaglinide statistics success type 2 diabetes in children volunteer

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英文摘要

The George Washington University Biostatistics Center proposes to serve as the Coordinating Center (CC) for the consortium of investigators being assembled by the NIDDK to conduct clinical trials of type 2 diabetes in children and adolescents. The consortium's objective is to develop and apply standardized methods, procedures, and measures to the conduct of (1) one multi-center, multi-arm clinical trial of treatment and (2) one or more primary prevention trials. Researchers and investigators from 6-10 clinical centers, the NIDDK, and the CC will comprise the consortium and collaborate under a cooperative agreement mechanism. This consortium will address the concern of health care researchers and providers over the steady and pernicious increase in detection of type 2 diabetes in youth both here and abroad. Knowing the consequences of type 2 diabetes in adults for micro- and macro-vascular disease progression, and knowing the role of adequate treatment and management, medical science seeks to broaden the scope of research to include treatment and prevention in this under-investigated and growing population of patients. The Steering Committee, composed of the principal investigators from the CC and each clinical center and the NIDDK project officer, will design and develop each of the clinical trials. The CC will provide centralized support and biostatistical consultation in: the development of protocols; manuals of procedures, data collection forms, and randomization procedures; implementation of a data management system including data quality assessment; interim analysis of protocol performance, patient safety, and treatment, efficacy; and final analysis for publication of results in collaboration with the clinical investigators. The CC will establish a secure encrypted and password protected web site for study staff to enhance development, distribution, and use of study documents. We have assembled a team of coordinating center staff and consultants with established credentials and experience in major diabetes research efforts, including the Diabetes Control and Complications Trial and the Diabetes Prevention Program.

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