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

 描述（由申请人提供）：超过25%的美国65岁以上人口患有2型糖尿病，其中80%的人超重或肥胖。这些人面临着缩短的寿命，增加的医疗保健需求，更大的医疗并发症，以及相对于没有这些条件的同龄人生活质量较低。建议对超重和肥胖的2型糖尿病患者进行以减肥为重点的生活方式干预，但这些干预措施是否能在长期随访中有意义地改善老年糖尿病患者的生活尚不清楚。Look AHEAD是一项随机试验，在超重和肥胖的2型糖尿病患者中比较了强化生活方式干预（ILI）的效果，重点是通过健康饮食和增加体力活动实现体重减轻，而对照组则给予糖尿病支持和教育（DSE）。虽然ILI没有对心血管疾病相关的主要和次要结局产生有益影响，但在干预期间，它确实对广泛的健康参数产生了有益影响。LA扩展（LA-E）将检查在中年期间提供10年的ILI是否具有持久的益处，这些益处在老年糖尿病患者的干预期之后持续存在。我们建议对大约3，800名参与者（目前年龄为58-89岁）进行额外4.5年的随访，每两年进行一次诊所访视，并进行6个月的电话随访。LA-E的主要目的是测试ILI相对于DSE是否对1）延长寿命和2）降低医疗保健成本具有长期遗留效应。次要目的是测试ILI相对于DSE是否对健康老龄化的关键方面有长期影响：减少虚弱，减少糖尿病微血管并发症，提高生活质量。LA-E还将比较体重、体力活动、脂肪和瘦体重以及骨密度的长期轨迹，并研究这些与结果的关系。LA-E侧重于与健康老龄化和恢复力最相关的临床结果，并将提供制定与生活方式干预相关的指南所需的长期数据， 2型糖尿病的治疗方法有哪些？

 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.