Diabetes Prevention Program

糖尿病预防计划

基本信息

批准号：
7189079
负责人：
TREVOR J. ORCHARD
金额：
$ 34.95万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
1994
资助国家：
美国
起止时间：
1994-08-15 至 2009-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7189079
关键词：
2,4-thiazolidinedione Accounting Address Adopted Adult Advisory Committees Affect African African American Age Age-Years Aging Albumins American Ankle Anthropometry Antioxidants Anxiety Appearance Appendix Arterial Fatty Streak Asians Asorbicap Atherosclerosis Autopsy Behavior Therapy Beta Cell Biochemical Biochemistry Blood Glucose Blood Pressure Body Weight decreased Budgets Calendar Caliber Cardiovascular Diseases Cardiovascular system Categories Caucasians Caucasoid Race Cell physiology Centers for Disease Control and Prevention (U.S.)Characteristics Cholesterol Chronic Chronic Disease Classification Clinical Clinical Research Clinical Trials Closure Cohort Effect Collaborations Collection Combined Modality Therapy Complication Complications of Diabetes Mellitus Conceptions Condition Consensus Control Groups Controlled Clinical Trials Controlled Study Coronary Coronary Arteriosclerosis Costs and Benefits Cox Models Creatinine Cross-Sectional Studies Cystatins Data Data Analyses Development Diabetes Mellitus Diabetes prevention Diabetic Angiopathies Diabetic Microangiopathies Diabetic Nephropathy Diabetic Retinopathy Diagnosis Diagnostic Dietary intake Disease Disease Outcome Disease regression Distal Dropout Dyslipidemias Economic Models Economics Effectiveness Effectiveness of Interventions Electrocardiogram End Point Enrollment Epidemiologic Studies Epidemiology Erythrocytes Ethnic Origin Evaluation Event Evolution Excretory function Exercise Exposure to Failure Fasting Fibrinogen Follow-Up Studies Frequencies Functional disorder Funding Fundus Fundus photography Gender General Population Glucose Glucose Intolerance Glucose tolerance test Goals Grant Graph Group Meetings Hazard Controls Health Health Benefit Health Care Costs Health Personnel Health Professional Healthcare Heart Diseases Hemoglobin Hemoglobin concentration result Hemostatic Agents Heterogeneity High Blood Pressure High Density Lipoprotein Cholesterol High Pressure Liquid Chromatography High Prevalence Hip region structure Hispanics Homocysteine Homocystine Hour Hyperglycemia Hyperlipidemia Hypertension Hypotension Impaired fasting glycaemia Incidence Individual Institutes Insulin Insulin Resistance Insulin-Dependent Diabetes Mellitus Intake Intention Intervention Intervention Studies Investigation Kidney Kidney Diseases Knowledge LDL Cholesterol Lipoproteins Laboratories Life Life Style Life Table Analyses Life Table Estimate Life Table Method Life Tables Light Linear Models Link Lipids Lipoproteins Living Costs Logistic Models Long-Term Effects Longitudinal Studies Low-Level Laser Therapy Masks Matched-Pair Analysis Measurement Measures Medial Medical History Medicine Mental Depression Metabolic Metformin Methods Michigan Microalbuminuria Microaneurysm Mind Minority Modeling Modification Monitor Morbidity - disease rate Multicenter Studies Myocardial Infarction National Eye Institute National Health and Nutrition Examination Survey National Institute of Diabetes and Digestive and Kidney Diseases Natural History Nature Neurologic Neuropathy Newly Diagnosed Nicotinic Acids Non-Insulin-Dependent Diabetes Mellitus Not Hispanic or Latino Numbers Nutrient OGTT Obesity Observational Study Ophthalmologist Organ Other Finding Outcome Outcome Measure Paired Comparison Paper Participant Particle Size Pathogenesis Patients Peripheral Nervous System Diseases Personal Satisfaction Persons Pharmaceutical Preparations Phase Photography Physical Examination Physical activity Pima Indian Placebos Plasma Plasminogen Activator Inhibitor 1 Play Population Population Study Populations at Risk Pre-study Predisposition Premenopause Prevalence Prevention Primary Prevention Principal Investigator Procedures Process Process Measure Prospective Studies Proteins Protocols documentation Psychological reinforcement Public Health Publishing Purpose Quality of life Quality-Adjusted Life Years Questionnaires Race Random Allocation Randomized Range Rate Reading Recommendation Recording of previous events Reflex action Relative (related person)Relative Risks Reporting Research Research Design Research Personnel Research Training Resistance Resources Retinal Diseases Risk Risk Estimate Risk Factors Risk Reduction Role SF-36 Sample Size Sampling Scanning Schedule Screening procedure Selection Bias Self-Administered Side Significance Level Sodium Chloride Somatomedins Specific qualifier value Spottings Staging Standards of Weights and Measures Statistically Significant Stratification Stroke Subgroup Suggestion Surveys Symptoms TNF gene Techniques Test Result Testing Thiazolidinediones Thick Thinking Ticks Time Tissues Touch sensation Translating Translations Treatment Effectiveness Triglycerides Ultrasonography United Kingdom United States Public Health Service Upper arm Uric Acid Urine Vascular Diseases Visit Visual Week Weight Wisconsin Woman World Health Organization adjudicate autonomic neuropathy base cardiovascular disorder risk cardiovascular risk factor clinical Diagnosis cohort comparison group cost cost effectiveness cysteine rich protein demographics design diabetes prevention program diabetes risk diabetic early onset epidemiology study experience follow-up glucose tolerance glycation glycemic control hazard illness length impaired glucose tolerance improved indexing insight instrument interest intervention program life time cost lifestyle intervention member men mortality non-diabetic oral glucose tolerance pre-clinical prevent prognostic programs prospective protocol development racial and ethnic sex size stereoscopic tool treatment duration treatment effect type I diabetic urinary volunteer young adult

项目摘要

DESCRIPTION (provided by applicant): The Diabetes Prevention Program is a multicenter controlled clinical trial examining the efficacy of an intensive life-style intervention or metformin to prevent or delay the development of diabetes in a population selected to be at high risk due to the presence of impaired glucose tolerance (IGT). Development of diabetes, defined by 1997 ADA criteria, is the primary outcome while cardiovascular disease and its risk factors are important secondary outcomes. The DPP began recruitment in mid-1996. At the time of this application, total study exposure is a mean of approximately 3 years (range 2 to 5) with a total of approximately 10,000 patient years in the 3,234 volunteers in the 3-arm study. On the basis of a statistically significant and clinically compelling decrease in the development of diabetes in the life-style intervention and metformin-treated groups (58% and 31% reductions, respectively) compared with the placebo treated group, the DPP Data Monitoring Board and NIDDK ended the masked treatment phase of the study in May, 2001, one year earlier than originally planned. This application is designed to take further advantage of the scientifically and clinically valuable cohort of DPP volunteers and the large volume of data collected during the study. The highly compliant DPP cohort, including 45% minorities, is the largest IGT population ever studied. Moreover, the subcohort that has developed diabetes (n approximately 700) has been followed from near the exact time of diabetes onset. Clinically important research questions remain in the wake of the DPP. The carefully collected, centrally measured and graded data in this cohort should help to answer, definitively, a number of important questions regarding the clinical course of IGT and early onset type 2 diabetes. Specific aims include: 1. Examine the long-term effects and durability of prior DPP intervention on the major DPP outcomes including diabetes, clinical cardiovascular disease, atherosclerosis, CVD risk factors, quality of life and cost-benefit; 2. Determine the clinical course of new onset type 2 diabetes and IGT, in particular regarding microvascular and neurologic complications; 3. Determine the incidence of cardiovascular disease (CVD), CVD risk factors and atherosclerosis in new onset type 2 diabetes and IGT; and 4. Examine topics 1-3 in minority populations, men vs. women, and in older subjects in the DPP. The current application is for 5 years of funding, although the some of the goals of the projects described will require a 10-year study.

描述（由申请人提供）：糖尿病预防计划是一项多中心对照临床试验，研究了强化生命式干预或二甲双胍的功效，以防止或延迟由于存在受损的葡萄糖耐受性（IGT）而被选择为高风险的糖尿病的发展。由1997年ADA标准定义的糖尿病的发展是主要结果心血管疾病及其危险因素是重要的次要结果。 DPP于1996年中开始招募。在此应用时，在3臂研究中，在3,234名志愿者中，总研究暴露是平均约3年（2至5），总计约10,000名患者年。根据统计学意义和临床引人注目的糖尿病发展的减少与安慰剂治疗组相比，经过二甲双胍治疗的组（分别减少58％和31％），DPP数据监测委员会和NIDDK结束了2001年5月的研究阶段，比最初计划的早一年。该应用程序旨在进一步利用DPP志愿者的科学和临床上有价值的队列以及研究期间收集的大量数据。高度兼容的DPP队列，包括45％的少数族裔，是有史以来最大的IGT人群。此外，子幼虫从糖尿病发作的确切时间附近，已经遵循了糖尿病（大约700个）。在DPP之后，临床上重要的研究问题仍然存在。该队列中精心收集的，中央测量和分级的数据应有助于回答有关IGT和早期发作2型糖尿病的许多重要问题。具体目的包括：1。检查先前DPP干预对主要DPP结果的长期影响和耐用性，包括糖尿病，临床心血管疾病，动脉粥样硬化，CVD风险因素，生活质量和成本效益； 2。确定新发作2型糖尿病和IGT的临床过程，特别是关于微血管和神经系统的临床过程并发症； 3。确定新发作2型糖尿病和IGT的心血管疾病（CVD），CVD危险因素和动脉粥样硬化的发生率；和4。在少数族裔，男性与女性以及DPP中的较旧受试者中检查主题1-3。当前的申请是5年的资金，尽管所述项目的某些目标将需要10年学习。