DPPOS Follow-up

DPPOS 跟进

• 批准号: 8852809
• 负责人: KISHORE M GADDE
• 金额: $ 24.65万
• 依托单位: LSU PENNINGTON BIOMEDICAL RESEARCH CTR
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-10-01 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8852809
• 关键词: Address; Adult; Affect; Age; Atherosclerosis; Biochemical; Blood Vessels; Cardiovascular Diseases; Caring; Clinical; Complications of Diabetes Mellitus; Development; Diabetes Mellitus; Diabetes prevention; Diagnosis; Disease; Disease Outcome; Effectiveness; Enrollment; Epidemiology; Evaluation; Event; Exposure to; Genotype; Glucose; Glycosylated hemoglobin A; Goals; Individual; Intention; Intervention; Label; Life Style; Living Costs; Long-Term Effects; Longitudinal Studies; Malignant Neoplasms; Measurable; Medicine; Metabolic; Metformin; Methods; Microvascular Dysfunction; Minority; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Outcome Study; Participant; Patients; Pharmaceutical Preparations; Phase; Phenotype; Physical Function; Placebos; Population; Prediabetes syndrome; Prevalence; Prevention; Public Health; Quality of life; Randomized; Regulation; Reporting; Risk; Risk Factors; Role; Safety; Specific qualifier value; Staging; Time; adjudicate; age effect; age related; aging population; base; cardiovascular disorder risk; clinically relevant; cognitive function; cohort; comparative effectiveness; cost; cost effective; diabetes prevention program; diabetic; economic impact; economic implication; effective intervention; follow-up; health economics; high risk; human disease; intervention effect; lifestyle intervention; mortality; novel; prevent; programs; public health relevance; success; treatment strategy

 DESCRIPTION (provided by applicant): Abnormal regulation of glycemia ("dysglycemia") has an extremely long time course, from its earliest stage, labeled pre-diabetes, to the onset of Type 2 diabetes (T2D), the development of clinically detectable microvascular changes and measurable atherosclerosis, to clinically manifest complications with attendant morbidity and mortality. The Diabetes Prevention Program (DPP) focused on the pre-diabetes stage of dysglycemia and demonstrated powerful beneficial effects of lifestyle intervention (ILS) and metformin (MET), compared with placebo, in preventing or delaying the onset of diabetes mellitus over a 3-year period in a high- risk population (n=3234). The DPP also described the role of phenotypic and genotypic risk factors associated with diabetes development, the factors that influenced the success of the interventions and health economic implications of diabetes prevention. On the basis of these results, the DPP lifestyle program has been widely implemented. The DPP Outcomes Study (DPPOS) explored the longer-term effects of T2D prevention, bridging the period between pre-diabetes and T2D over 11 years of follow-up, to examine outcomes that required more time to develop than the relatively brief 3 years of DPP (n=2776). DPPOS showed longer-term salutary effects of the original interventions on T2D prevention and on cardiovascular disease (CVD) risk factors. Prevention was cost-saving with MET and cost-effective with ILS. Although the aggregate microvascular outcome was not significantly reduced by either active intervention, those in whom T2D was prevented had a 28% lower risk of developing microvascular complications compared with those who developed T2D. The risk of complications was associated with T2D duration and HbA1c levels. The proposed project (DPPOS Follow-up), will study the DPPOS cohort for 10 more years, taking advantage of the long-term randomized exposure to MET and the densely phenotyped and genotyped DPPOS cohort (n=2776), including ~1500 patients with known T2D duration and ~1200 who have not developed T2D, to address yet unanswered questions about long-term exposure to MET and ILS initiated early in the course of dysglycemia. DPPOS Follow-up will examine outcomes that are of increasing public health concern in an aging population with pre-diabetes and T2D, including the development of CVD, cancer, and concomitant quality of life. The overarching goals of DPPOS Follow-up are to examine efficiently: 1) the putative benefits of metformin therapy begun early in the prediabetic phase on risk for CVD and cancer; 2) the very long-term effects of T2D prevention with ILS and MET by intention-to-treat on further development of diabetes, and on traditional and more recently recognized complications of dysglycemia; and 3) the modern day clinical course of dysglycemia and its associated complications, based on both categorical diagnoses (pre-diabetes vs. diabetes) as well as a continuum, including a careful analysis of interactions with DPP interventions as well as established and novel risk factors.

 描述（适用提供）：血糖异常调节（“血糖症”）的时间非常长，从最早的阶段，糖尿病前标签到2型糖尿病（T2D）的发作（T2D），临床上可检测到的微血管变化和可测量的动脉粥样硬化的发展，到临床上的临床上的临床表现，到临床上可检测到的出现。糖尿病预防计划（DPP）着重于血糖前糖尿病前阶段，与安慰剂相比，与安慰剂相比，生活方式干预（ILS）和二甲双胍（MET）表现出强大的有益作用，以预防或延迟糖尿病的发作，在高风险的人群中，在3年内（N = 32234）。 DPP还描述了与糖尿病发育相关的表型和基因型危险因素的作用，这些因素影响了预防糖尿病的干预措施和健康经济影响的因素。根据这些结果，DPP生活方式计划已被广泛实施。 DPP结果研究（DPPO）探讨了预防T2D的长期影响，在11年的随访中弥合了糖尿病前和T2D之间的周期，以检查比相对三年的DPP相对短暂的3年（n = 2776）所需的时间来发展的结果（n = 2776）。 DPPO显示出原始干预措施对T2D预防和心血管疾病（CVD）危险因素的长期有益影响。与IL相关的MET和具有成本效益的预防措施可节省成本。尽管两种主动干预措施都没有显着降低微血管的总结局，但与开发T2D相比，预防T2D的人的微血管效果的风险低28％。并发症的风险与T2D持续时间和HBA1C水平有关。拟议的项目（DPPO随访）将利用长期的随机接触MET和令人垂涎的和基因型的DPPOS群（n = 2776）的长期随机暴露（包括约1500名已知T2D持续时间的患者，以及未开发的T2D尚未启动的情况下，还没有持续启动，还包括约1500名患者，还包括约1500例，尚未启动，并且均不在启动时，将遇到了暂时的曝光，并在未经启动的过程中启动了〜1500名患者血糖症。 DPPO的随访将检查糖尿病前和T2D的老龄化人群中增加公共卫生问题的结果，包括CVD，癌症的发展和伴随的生活质量。 DPPO随访的总体目标是有效检查：1）二甲双胍治疗的假定益处从糖尿病前期开始的CVD和癌症风险开始； 2）预防T2D对IL的长期影响，并通过意图对待对糖尿病的进一步发展以及最近公认的血糖并发症的进一步发展； 3）基于分类诊断（糖尿病前与糖尿病前）以及连续体的现代性血糖及其相关并发症的现代临床过程，包括对与DPP干预措施的相互作用以及确定的危险因素的仔细分析和新颖的风险因素。