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糖尿病患者控制心血管风险行动(ACCORD)记忆研究:原理、设计与方法

The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods.

作者信息

Williamson Jeff D, Miller Michael E, Bryan R Nick, Lazar Ronald M, Coker Laura H, Johnson Janice, Cukierman Tali, Horowitz Karen R, Murray Anne, Launer Lenore J

机构信息

Roena B. Kulynych Center for Memory, Cognition Research, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.

出版信息

Am J Cardiol. 2007 Jun 18;99(12A):112i-122i. doi: 10.1016/j.amjcard.2007.03.029. Epub 2007 Apr 12.

DOI:10.1016/j.amjcard.2007.03.029
PMID:17599421
Abstract

Type 2 diabetes mellitus and cognitive impairment are 2 of the most common chronic conditions found in persons aged > or = 60 years. Clinical studies have shown a greater prevalence of global cognitive impairment, incidence of cognitive decline, and incidence of Alzheimer disease in patients with type 2 diabetes. To date, there have been no randomized trials of the effects of long-term glycemic control on cognitive function and structural brain changes in patients with type 2 diabetes. The primary aim of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Memory in Diabetes Study (ACCORD-MIND) is to test whether there is a difference in the rate of cognitive decline and structural brain change in patients with diabetes treated with standard-care guidelines compared with those treated with intensive-care guidelines. This comparison will be made in a subsample of 2,977 patients with diabetes participating in the ongoing ACCORD trial, a clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI) with support from the National Institute on Aging (NIA). Data from this ACCORD substudy on the possible beneficial or adverse effects of intensive treatment on cognitive function will be obtained from a 30-minute test battery, administered at baseline and 20-month and 40-month visits. In addition, full-brain magnetic resonance imaging will be performed on 630 participants at baseline and at 40 months to assess the relation between the ACCORD treatments and structural brain changes. The general aim of ACCORD-MIND is to determine whether the intensive treatment of diabetes, a major risk factor for Alzheimer disease and vascular dementia, can reduce the early decline in cognitive function that could later evolve into more cognitively disabling conditions. This report presents the design, rationale, and methods of the ACCORD-MIND substudy.

摘要

2型糖尿病和认知障碍是60岁及以上人群中最常见的两种慢性病。临床研究表明,2型糖尿病患者中全球认知障碍的患病率更高、认知功能下降的发生率以及阿尔茨海默病的发生率更高。迄今为止,尚无关于长期血糖控制对2型糖尿病患者认知功能和脑结构变化影响的随机试验。糖尿病心血管风险控制行动(ACCORD)糖尿病记忆研究(ACCORD-MIND)的主要目的是测试,与接受强化治疗指南的患者相比,接受标准治疗指南的糖尿病患者在认知功能下降率和脑结构变化方面是否存在差异。这种比较将在参与正在进行的ACCORD试验的2977名糖尿病患者的子样本中进行,该临床试验由美国国立心肺血液研究所(NHLBI)发起,并得到美国国立衰老研究所(NIA)的支持。来自ACCORD子研究的关于强化治疗对认知功能可能的有益或不利影响的数据,将通过一个30分钟的测试组合获得,该测试组合在基线、第个月和第40个月就诊时进行。此外,将在630名参与者的基线和第40个月时进行全脑磁共振成像,以评估ACCORD治疗与脑结构变化之间的关系。ACCORD-MIND的总体目标是确定糖尿病(阿尔茨海默病和血管性痴呆的主要危险因素)的强化治疗是否可以减少认知功能的早期下降,而这种下降可能随后发展为更严重的认知障碍。本报告介绍了ACCORD-MIND子研究的设计、基本原理和方法。

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