Intensive Glycemic Control and Skeletal Health

强化血糖控制和骨骼健康

• 批准号: 7660507
• 负责人: ANN V SCHWARTZ
• 金额: $ 43.8万
• 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 2011-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7660507
• 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; DEXA; Diabetes Mellitus; Doctor of Philosophy; Elderly; Event; Fall prevention; Fracture; Frequencies; Guidelines; Hand; Health; Height; Hemoglobin; Hip region structure; Hyperglycemia; Hypoglycemia; 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; Reporting; Retinal Diseases; Risk; Risk Factors; Severities; Shoulder; Spinal Fractures; Testing; Vertebral column; Visual impairment; adjudicate; bone; bone cell; bone loss; bone strength; burden of illness; cardiovascular risk factor; diabetes control; diabetic; experience; falls; foot; glycemic control; high risk; improved; middle age; skeletal; trial comparing

DESCRIPTION (provided by applicant): Older adults with type 2 diabetes have a higher risk of fractures, adding to the health burden of this disease. More frequent falls 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 osteoporosis should 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 Action to 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 approximately 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 reported fractures 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).

描述（由申请人提供）：2型糖尿病老年人骨折的风险较高，增加了这种疾病的健康负担。糖尿病患者更频繁的福尔斯跌倒和可能降低的骨强度被认为是关键的促成因素。然而，目前尚不清楚更好地控制糖尿病是否足以降低骨折风险，或者是否应给予骨质疏松症的额外治疗。观察性研究表明，改善血糖控制可通过预防福尔斯、降低福尔斯的严重程度和减少骨丢失来降低骨折风险。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，这些都是福尔斯的危险因素。强化血糖控制可通过降低骨中晚期糖基化终产物水平、改善骨细胞功能和减少骨丢失来保持骨强度。另一方面，伴随严格血糖控制的低血糖发作增加可促进老年糖尿病人群的福尔斯，导致骨折风险增加。为了确定强化血糖控制是否可作为预防老年糖尿病患者骨折、福尔斯和/或骨质流失的措施，我们建议在最近启动的控制糖尿病心血管风险的临床试验（雅阁）中增加骨折、福尔斯和骨密度的措施。雅阁将对10，000名患有2型糖尿病的中年和老年人（平均年龄63岁）进行平均5.6年的随访，以确定强化（A1 C < 6%）与标准（A1 C约7.5%）血糖控制是否会减少心血管事件。我们假设，与随机分配到标准对照组的患者相比，随机分配到强化对照组的患者骨折发生率较低，福尔斯发生频率较低，骨丢失减少。在7，145名雅阁参与者中，骨折和福尔斯将通过每12个月自我报告确定，报告的骨折使用医疗记录集中裁定。将使用双能吸收测定法（DEXA）在子样本（N=240）中测定髋关节和腰椎两年内的骨矿物质密度变化。