13/16 Action for Health in Diabetes Extension Study Research Project

 描述(由申请人提供)：超过25%的65岁的美国人患有2型糖尿病，其中80%的人超重或肥胖。与没有这些疾病的同龄人相比，这些人面临寿命缩短、卫生保健需求增加、更严重的医疗并发症和较低的生活质量。对于患有2型糖尿病的超重和肥胖患者，建议采取以减肥为重点的生活方式干预措施，但这些干预措施是否通过延长随访时间有效改善老年糖尿病患者的生活尚不清楚。前瞻是一项随机试验，比较了通过健康饮食和增加体力活动实现减肥的强化生活方式干预(ILI)与接受糖尿病支持和教育(DSE)的对照组在超重和肥胖2型糖尿病患者中的效果。尽管ILI对与心血管疾病相关的一级和二级结果没有产生有益的影响，但在干预期间，它确实对广泛的健康参数产生了有益的影响。LA延期(LA-E)将检查中年期间提供10年的ILI是否具有持续到老年糖尿病患者干预期后的益处。我们建议对大约3800名参与者(目前年龄58-89岁)进行为期4.5年的跟踪调查，每两年进行一次诊所访问，并对6个月的结果进行电话交谈。LA-E的主要目的是测试相对于DSE的ILI是否在1)延长寿命和2)降低医疗成本方面具有长期遗留影响。二级目标测试相对于DSE的ILI是否对健康老龄化的关键维度有长期影响：更少的虚弱，减少糖尿病微血管并发症，以及改善生活质量。LA-E还将比较体重、体力活动、脂肪和瘦肉质量以及骨密度的长期轨迹，并检查这些指标与结果的关系。LA-E侧重于与健康老龄化和韧性最相关的临床结果，并将提供所需的长期数据，以制定与生活方式干预相关的指南 老年超重或肥胖2型糖尿病患者的护理。

 DESCRIPTION (provided by applicant): Over 25% of the US population >65 years of age have type 2 diabetes and 80% of these individuals are overweight or obese. These individuals face shortened lifespans, increased health care needs, greater medical complications, and lower quality of life relative to those of similar age without these conditions. Lifestyle interventions focused on weight loss are recommended for overweight and obese individuals with type 2 diabetes, but whether these interventions meaningfully improve the lives of older individuals with diabetes over extended follow-up is unknown. Look AHEAD is a randomized trial comparing the effects of intensive lifestyle intervention (ILI) focused on weight loss achieved through healthy eating and increased physical activity versus a control group given Diabetes Support and Education (DSE) in overweight and obese individuals with type 2 diabetes. Although ILI did not produce beneficial effects on the primary and secondary outcomes related to cardiovascular disease, it did produce beneficial effects on a broad spectrum of health parameters during the period of the intervention. The LA Extension (LA-E) will examine whether ILI, provided for 10 years during mid- life, has enduring benefits that persist beyond the period of the intervention for older individuals with diabetes. We propose to follow approximately 3,800 participants (current ages 58-89 years) for 4.5 additional years with biennial clinic visits and 6-month outcomes phone calls. The primary aims of LA-E are to test whether ILI relative to DSE has long term legacy effects on 1) increased lifespan and 2) reduced health care costs. Secondary aims test whether ILI relative to DSE has long-term effects on key dimensions of healthy aging: less frailty, reduced diabetic microvascular complications, and improved quality of life. LA-E will also compare long- term trajectories of weight, physical activity, fat and lean mass, and bone density and examine how these are related to outcomes. LA-E focuses on the clinical outcomes that are most relevant to healthy aging and resilience and will provide the long-term data needed to frame guidelines related to lifestyle intervention in the care of older overweight or obese individuals with type 2 diabetes.