Diabetes Prevention Program Long-Term Follow-up Study

糖尿病预防计划长期随访研究

基本信息

批准号：
7189018
负责人：
XAVIER PI-SUNYER
金额：
$ 25.06万
依托单位：
ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS
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/7189018
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 Behavioral Beta Cell Biochemical Biochemistry Blood Glucose Blood Pressure Body Weight decreased Budgets Calendar Caliber Cardiovascular Diseases Cardiovascular system Caring Categories Caucasians Caucasoid Race Cell physiology 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-Like Growth Factor I Intake Intention Intervention Intervention Studies Kidney Kidney Diseases Knowledge LDL Cholesterol Lipoproteins Laboratories Left 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 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 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 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 Screening procedure Selection Bias Self-Administered Side Significance Level Sodium Chloride 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 Work 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检查强化生活方式干预或二甲双胍的功效在选定的人群中预防或延缓糖尿病的发展由于存在糖耐量受损 (IGT)，因此存在高风险。发展 1997 年 ADA 标准定义的糖尿病的发生是主要结局，而心血管疾病及其危险因素是重要的次要结局。民进党于1996年中开始招募。在提出本申请时，总计研究暴露时间平均约为 3 年（范围 2 至 5），总计三臂组的 3,234 名志愿者中约有 10,000 个患者年学习。基于统计学上显着且具有临床说服力的生活方式干预可减少糖尿病的发生，与二甲双胍治疗组相比（分别减少 58% 和 31%）安慰剂治疗组、DPP 数据监测委员会和 NIDDK 结束了该研究的隐蔽治疗阶段于 2001 年 5 月进行，比原本计划的。该应用程序旨在进一步利用科学具有临床价值的 DPP 志愿者队列和大量数据研究期间收集的。高度顺从的民进党群体，包括 45% 少数民族，是有史以来研究的最大的 IGT 人群。此外，子队列患有糖尿病的人（大约 700 人）已被跟踪近糖尿病发病的确切时间。临床重要的研究问题继续追随民进党。精心收集、集中测量和该队列中的分级数据应该有助于明确地回答一些问题关于 IGT 和早发型 2 型临床病程的重要问题糖尿病。具体目标包括： 1. 检查长期影响和先前 DPP 干预对主要 DPP 结果的持久性，包括糖尿病、临床心血管疾病、动脉粥样硬化、CVD 危险因素、生活质量和成本效益； 2. 确定新发临床病程 2 型糖尿病和 IGT，特别是微血管和神经系统方面并发症； 3.确定心血管疾病（CVD）的发生率、CVD 新发 2 型糖尿病和 IGT 的危险因素和动脉粥样硬化；和 4. 检查少数民族人口、男性与女性以及老年人中的主题 1-3 民进党的主题。目前的申请为期5年，尽管所描述的项目的一些目标需要 10 年的时间学习。