Background: Both hypertension and diabetes are risk factors of dementia. Proper management of blood pressure (BP) and blood glucose is critical in delaying cognitive decline in the elderly. However, little is known regarding the optimal BP target in type 2 diabetes (T2DM) for the management of cognitive decline.
Methods: The Blood Pressure Control Target in Diabetes (BPROAD) study is a nationwide, multicenter, randomized controlled trial that will enroll 12 702 T2DM patients with elevated systolic BP and increased cardiovascular risk from approximately 150 study centers across mainland China to undergo randomly antihypertensive treatment achieving systolic BP <120 mm Hg or systolic BP <140 mm Hg for up to 5 years. All BPROAD participants will take part in the BPROAD Cognitive Study for the assessment of cognitive function at baseline and annual visits by blinded outcome assessors to determine whether intensive BP treatment reduces risk of dementia and mild cognitive impairment (MCI) compared with standard BP treatment in patients with T2DM. In addition, approximately 1000 BPROAD participants will be enrolled in the magnetic resonance imaging (MRI) substudy to receive brain MRI at baseline and at closeout. The primary outcome of BPROAD Cognitive Study is a composite of all-cause dementia and MCI.
Conclusions: The BPROAD Cognitive Study will provide crucial clinical trial data on the possible benefit of an intensive systolic BP lowering strategy in reducing dementia and MCI in patients with T2DM.
背景:高血压和糖尿病都是痴呆症的风险因素。适当地管理血压(BP)和血糖是延缓老年人认知下降的关键。然而，对于2型糖尿病(T2DM)认知减退管理的最佳BP目标值知之甚少。 方法:BPROAD研究是一项全国性多中心随机对照试验，将招募12,702名T2DM患者。这些患者来自中国大陆约150个研究中心，患者的收缩压升高，心血管风险增加。所有BPROAD参与者将参加BPROAD认知研究，以评估基线和年度访问时的认知功能，由盲态的结果评估员确定与标准BP治疗相比，强化BP治疗是否可降低T2DM患者的痴呆和轻度认知障碍(MCI)风险。此外，约1,000名BPROAD参与者将参加磁共振成像(MRI)亚组研究，在基线和4年随访中接受脑部MRI检查。BPROAD认知研究的主要结果是所有原因的痴呆症和MCI的复合指标。 结论:BPROAD认知研究将为减少T2DM患者的痴呆症和MCI提供关键的临床试验数据。.
Keywords: 2型糖尿病; blood pressure; dementia; mild cognitive impairment; randomized controlled trial; type 2 diabetes; 痴呆症; 血压; 轻度认知障碍; 随机对照试验.
© 2023 The Authors. Journal of Diabetes published by Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.