A Prospective Longitudinal Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Type 2 Diabet
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STUDY PROTOCOL
A Prospective Longitudinal Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Type 2 Diabetes: PROPOSAL Study Protocol Masaki Matsubara . Hisashi Makino
. Kazuo Washida . Miki Matsuo .
Ryo Koezuka . Yoko Ohata . Tamiko Tamanaha . Kyoko Honda-Kohmo . Michio Noguchi . Tsutomu Tomita . Cheol Son . Michikazu Nakai . Kunihiro Nishimura . Yoshihiro Miyamoto . Masafumi Ihara . Kiminori Hosoda
Received: July 8, 2020 Ó The Author(s) 2020
ABSTRACT 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 Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12826286. M. Matsubara H. Makino (&) M. Matsuo R. Koezuka Y. Ohata T. Tamanaha K. Honda-Kohmo M. Noguchi T. Tomita C. Son K. Hosoda Division of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan e-mail: [email protected] K. Washida M. Ihara Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan M. Nakai Y. Miyamoto Center for Cerebral and Cardiovascular Disease Information, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan K. Nishimura Department of Preventive Medicine and Epidemiology, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan
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, singlecenter, 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.
Diabetes Ther
Planned Outcomes: The current study is scheduled for complet
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