J Diabetes. 2023 Dec;15(12):1041-1047. doi: 10.1111/1753-0407.13412. Epub 2023 Sep 22.
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.
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.
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.
高血压和糖尿病都是痴呆的危险因素。适当控制血压(BP)和血糖对于延缓老年人认知能力下降至关重要。然而,对于 2 型糖尿病(T2DM)患者管理认知下降的最佳 BP 目标知之甚少。
血压控制目标在糖尿病(BPROAD)研究是一项全国性、多中心、随机对照试验,将从中国大陆约 150 个研究中心招募 12702 例伴有收缩压升高和心血管风险增加的 T2DM 患者,进行随机降压治疗,使收缩压<120mmHg 或收缩压<140mmHg 持续 5 年。所有 BPROAD 参与者将参加 BPROAD 认知研究,以评估基线和每年的认知功能,由盲法结局评估者确定强化 BP 治疗是否比 T2DM 患者的标准 BP 治疗降低痴呆和轻度认知障碍(MCI)的风险。此外,大约 1000 名 BPROAD 参与者将被纳入磁共振成像(MRI)子研究,以在基线和结束时接受脑部 MRI。BPROAD 认知研究的主要结局是全因痴呆和 MCI 的复合结局。
BPROAD 认知研究将提供关于强化收缩压降低策略在降低 T2DM 患者痴呆和 MCI 风险方面可能获益的重要临床试验数据。