Intensive Glycemic Control and Skeletal Health

强化血糖控制和骨骼健康

• 批准号: 7477402
• 负责人: ANN V SCHWARTZ
• 金额: $ 5.18万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-15 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7477402
• 关键词: Adult; Advanced Glycosylation End Products; Age; Ancillary Study; Bone Density; Cardiovascular system; Cell physiology; Clinical; Clinical Trials; Cohort Studies; Collagen; Complications of Diabetes Mellitus; Diabetes Mellitus; Doctor of Philosophy; Elderly; Event; Fall prevention; Fracture; Frequencies; Guidelines; Hand; Health; Height; Hemoglobin; Hip region structure; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Individual; Measures; Medical Records; Neck; Non-Insulin-Dependent Diabetes Mellitus; Observational Study; Osteoporosis; Participant; Patient Self-Report; Peripheral Nervous System Diseases; Pharmaceutical Preparations; Population; Prevention; Prophylactic treatment; Randomized; Rate; Retinal Diseases; Risk; Risk Factors; Severities; Shoulder; Skeletal system; Spinal Fractures; Standards of Weights and Measures; Testing; Thinking; Vertebral column; Visual impairment; adjudicate; bone; bone cell; bone loss; bone strength; burden of illness; cardiovascular risk factor; diabetic; experience; falls; foot; glycemic control; improved; middle age; trial comparing

Older adults with type 2 diabetes have a higher risk of fractures, adding to the health burden of this disease. More frequentfalls and perhaps reduced bone strength in those with diabetes are thought to be key contributing factors. However, it is not clear whether better control of diabetes is sufficient to reduce fracture risk or whether additional treatment for osteoporosisshould be given. Observational studies suggest that improved glycemic control may reduce fracture risk by preventing falls, decreasing the severity of falls, and reducing bone loss. Previous trials have demonstrated that improved control reduces diabetic complications, particularly peripheral neuropathy and retinopathy, that are risk factors for falls. Intensive glycemic control may preserve bone strength through reduced levels of advanced glycation endproducts in the bone, improved bone cell function, and reduced bone loss. On the other hand, increased hypoglycemic episodes accompanying tight glycemic control could promote falls in the older diabetic population, resulting in an increased risk of fracture. In order to determine whether intensive glycemic control is useful as a prevention measure for fractures, falls and/or bone loss in older diabetic adults, we propose adding measures of fractures, falls and bone mineral density to the recently initiated clinical trial Actionto Control Cardiovascular Risk in Diabetes (ACCORD). ACCORD will follow 10,000 middle-aged and older adults (average age 63 years) with type 2 diabetes for an average of 5.6 years to determine if cardiovascular events are reduced by intensive (A1C < 6%) versus standard (A1C ~ 7.5%) glycemic control. We hypothesize that those randomized to intensive control will have a lower rate of fractures, less frequent falls, and reduced bone loss compared with those randomized to standard control. In 7,145 of the ACCORD participants, fractures and falls will be determined by self-report every 12 months, with reportedfractures adjudicated centrally using medical records. Change in bone mineral density over two years at the hip and lumbar spine will be determined in a subsample (N=240) using dual energy absorptiometry(DEXA).

患有2型糖尿病的老年人骨折的风险更高，增加了这种疾病的健康负担。 糖尿病患者跌倒的频率更高，骨骼强度可能降低，这被认为是关键 影响因素。然而，目前尚不清楚更好的糖尿病控制是否足以减少骨折 风险或是否应该给予额外的骨质疏松症治疗。观察性研究表明 改善血糖控制可以通过预防跌倒、降低跌倒的严重性以及 减少骨质流失。以前的试验已经证明，改善控制可以减少糖尿病 并发症，特别是周围神经病变和视网膜病变，是跌倒的危险因素。集约化 血糖控制可能通过降低晚期糖基化终末产物水平来保持骨强度 改善骨细胞功能，减少骨质流失。另一方面，增加了降血糖 伴随着严格的血糖控制的发作可能会促进老年糖尿病人群的下降，从而导致 增加了骨折的风险。为了确定强化血糖控制是否有用 老年糖尿病患者骨折、跌倒和/或骨质丢失的预防措施，我们建议增加 骨折、跌倒和骨密度测量对近期启动的临床试验的控制作用 糖尿病的心血管风险(ACCORD)。ACCORD将跟踪10,000名中老年人 (平均年龄63岁)2型糖尿病患者的平均年龄为5.6年，以确定是否患有心血管疾病 强化血糖控制(A1C&lt；6%)与标准血糖控制(A1C~7.5%)相比，事件减少。我们 假设那些随机接受强化控制的患者骨折发生率较低，跌倒频率较低， 与随机接受标准对照的患者相比，减少了骨丢失。在协议的7,145条中 参与者、骨折和跌倒将每12个月通过自我报告确定，并报告骨折 使用病历进行集中评判。两年来髋部和髋部骨密度的变化 腰椎将在一个子样本(N=240)中使用双能量吸收法(DEXA)进行测定。