Intensive Glycemic Control and Skeletal Health

强化血糖控制和骨骼健康

• 批准号: 6965816
• 负责人: ANN V SCHWARTZ
• 金额: $ 51.18万
• 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/6965816
• 关键词: accidental falls; blood glucose; bone density; bone fracture; cardiovascular disorder risk; clinical research; diabetes mellitus therapy; disease /disorder proneness /risk; human subject; noninsulin dependent diabetes mellitus; patient care management; questionnaires

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）：患有2型糖尿病的老年人的骨折风险更高，增加了这种疾病的健康负担。糖尿病患者中更频繁的跌倒，骨骼强度可能会降低，被认为是关键的因素。但是，目前尚不清楚更好地控制糖尿病的人足以降低骨折风险，还是应给予骨质疏松症的其他治疗方法。观察性研究表明，改善血糖控制可以通过防止跌倒，降低跌倒的严重程度并减少骨质流失来降低骨折风险。先前的试验表明，改善的控制可减少糖尿病并发症，尤其是周围神经病和视网膜病，这是跌倒的危险因素。强化血糖控制可以通过降低骨骼中晚期糖基化最终产物的水平，改善骨细胞功能并减少骨质流失，从而保持骨骼强度。另一方面，伴随严重血糖控制的降血糖发作增加可能会促进较老的糖尿病人群的跌倒，从而导致骨折风险增加。为了确定强化血糖控制是否可作为较老糖尿病成年人的裂缝，跌倒和/或骨质损失的预防措施，我们建议在最近开始的临床试验行动中增加骨折，下降和骨矿物质密度的措施，以控制糖尿病中的心血管风险（ACCONC）。协定将遵循10,000名中年和老年人（平均63岁），平均2.6岁的糖尿病，以确定心血管事件是否通过强化（A1C <6％）而降低了心血管事件（A1C <6％）与标准（A1C约7.5％）血糖控制。我们假设与随机对标准对照组相比，那些随机进行密集控制的人的断裂率较低，跌落频率较低，而骨质流失减少。在7,145个协议参与者中，裂缝和跌倒将由一次自我报告确定，报告使用医疗记录进行中心裁决。在髋关节和腰椎两年内，骨矿物质密度的变化将在子样本（n = 240）中使用双能吸收仪（DEXA）确定。