一项关于2型糖尿病患者血糖波动与认知功能关系的前瞻性纵向研究：PROPOSAL研究方案。
A Prospective Longitudinal Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Type 2 Diabetes: PROPOSAL Study Protocol.
作者信息
Matsubara Masaki, Makino Hisashi, Washida Kazuo, Matsuo Miki, Koezuka Ryo, Ohata Yoko, Tamanaha Tamiko, Honda-Kohmo Kyoko, Noguchi Michio, Tomita Tsutomu, Son Cheol, Nakai Michikazu, Nishimura Kunihiro, Miyamoto Yoshihiro, Ihara Masafumi, Hosoda Kiminori
机构信息
Division of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
出版信息
Diabetes Ther. 2020 Nov;11(11):2729-2737. doi: 10.1007/s13300-020-00916-9. Epub 2020 Sep 5.
INTRODUCTION
Although the risk of dementia among patients with type 2 diabetes mellitus (T2DM) is double that of those without T2DM, the mechanism remains to be elucidated and the glycemic goal to prevent progression of cognitive impairment is unclear. Results from cross-sectional studies suggest that glucose fluctuations are associated with impairment of cognitive function among T2DM patients. Therefore, the aim of the longitudinal study described here is to evaluate the relationships between glucose fluctuation indexes assessed by continuous glucose monitoring (CGM) and cognitive function among elderly patients with T2DM.
METHODS
This will be a prospective, single-center, 2-year longitudinal study in which a total of 100 elderly patients with T2DM showing mild cognitive impairment (MCI) will be enrolled. Glucose fluctuations, assessed using the FreeStyle Libre Pro continuous glucose monitoring system (Abbott Laboratories), and results of cognitive tests, namely the Montreal Cognitive Assessment (MoCA) and Alzheimer's Disease Assessment Scale (ADAS), will be evaluated at baseline, 1-year visit and 2-year visit. The primary endpoint is the relationships between indexes of glucose fluctuation and change in MoCA and ADAS scores. Secondary endpoints are the relationships between the indexes of glucose fluctuation or cognitive scores and the following: indexes representing intracranial lesions obtained by magnetic resonance imaging and angiography of the head; Geriatric Depression Scale score; Apathy Scale score; carotid intima-media thickness assessed by echography; inflammatory markers; fasting glucose; glycated hemoglobin; blood pressure; and the development of cardiovascular and renal events.
PLANNED OUTCOMES
The current study is scheduled for completion in June 2022. The results could lead to the elucidation of novel glycemic goals to prevent the progression of cognitive impairment and/or of relationships between glucose fluctuations and cognitive function among T2DM patients. The findings of the study will be reported in publications and conference presentations.
TRIAL REGISTRATION
University Hospital Medical Information Network Clinical Trial Registry (UMIN000038546).
引言
尽管2型糖尿病（T2DM）患者患痴呆症的风险是未患T2DM患者的两倍，但其机制仍有待阐明，且预防认知功能障碍进展的血糖目标尚不清楚。横断面研究结果表明，血糖波动与T2DM患者的认知功能损害有关。因此，本文所述纵向研究的目的是评估通过持续葡萄糖监测（CGM）评估的血糖波动指标与老年T2DM患者认知功能之间的关系。
方法
这将是一项前瞻性、单中心、为期2年的纵向研究，共纳入100名患有轻度认知障碍（MCI）的老年T2DM患者。使用FreeStyle Libre Pro持续葡萄糖监测系统（雅培实验室）评估血糖波动，并在基线、1年随访和2年随访时评估认知测试结果，即蒙特利尔认知评估（MoCA）和阿尔茨海默病评估量表（ADAS）。主要终点是血糖波动指标与MoCA和ADAS评分变化之间的关系。次要终点是血糖波动指标或认知评分与以下各项之间的关系：通过头部磁共振成像和血管造影获得的代表颅内病变的指标；老年抑郁量表评分；淡漠量表评分；通过超声检查评估的颈动脉内膜中层厚度；炎症标志物；空腹血糖；糖化血红蛋白；血压；以及心血管和肾脏事件的发生情况。
预期结果
本研究计划于2022年6月完成。研究结果可能有助于阐明预防认知功能障碍进展的新血糖目标和/或T2DM患者血糖波动与认知功能之间的关系。该研究的结果将在出版物和会议报告中公布。
试验注册
大学医院医学信息网络临床试验注册中心（UMIN000038546）。
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