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Protocol of a Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cardiovascular Events in Patients with Type 2 Diabetes
http://hdl.handle.net/2241/00159821
http://hdl.handle.net/2241/0015982100310174-1ef3-45ae-a099-c079017ec25a
名前 / ファイル | ライセンス | アクション |
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DT_10-5 (324.8 kB)
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Item type | Journal Article(1) | |||||
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公開日 | 2020-03-23 | |||||
タイトル | ||||||
言語 | en | |||||
タイトル | Protocol of a Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cardiovascular Events in Patients with Type 2 Diabetes | |||||
言語 | ||||||
言語 | eng | |||||
資源タイプ | ||||||
資源 | http://purl.org/coar/resource_type/c_6501 | |||||
タイプ | journal article | |||||
著者 |
五所, 正彦
× 五所, 正彦× Mita, Tomoya× Katakami, Naoto× Okada, Yosuke× Yoshii, Hidenori× Osonoi, Takeshi× Nishida, Keiko× Shiraiwa, Toshihiko× Torimoto, Keiichi× Kurozumi, Akira× Wakasugi, Satomi× Shimomura, Iichiro× Watada, Hirotaka |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Introduction A recent study demonstrated that large glucose fluctuations were associated with an increased incidence of cardiovascular disease (CVD) in patients with type 2 diabetes mellitus (T2DM) and acute myocardial infarction. However, it is unknown whether glucose fluctuations are related to the incidence of CVD or the progression of atherosclerosis in patients with T2DM with no apparent history of CVD. In this protocol, we will be investigating the relationships of glucose fluctuations evaluated by continuous glucose monitoring (CGM) to the incidence of composite cardiovascular events and the progression of atherosclerosis in patients with T2DM who had no apparent history of CVD. Methods This is a prospective, multicenter, 5-year follow-up observational study. Between April 2018 and October 2019, 1000 participants are expected to be recruited at 34 medical institutions. CGM using FreeStyle Libre Pro is useful for evaluating glucose fluctuations by continuously monitoring glucose levels in interstitial fluid for up to 14 days. The primary study outcome is the relationship between fluctuations in glucose levels evaluated by CGM and the incidence of composite cardiovascular events. Secondary outcomes include the relationships of fluctuations in glucose levels evaluated by CGM to changes in carotid intima media thickness evaluated by echography or grayscale median (an index of tissue characteristics of the carotid wall), brachial–ankle pulse wave velocity, development or progression of diabetic retinopathy or nephropathy, quality-of-life-related diabetes therapy, quality of sleep, development of dementia, and autonomic nerve function. Planned Outcome This protocol is designed to investigate the relationship between glucose fluctuations and the incidence of composite cardiovascular events. We completed the registration of 1000 participants in March 2019. Thus, results will be available in 2024. We expect that evaluating glucose fluctuations will aid the identification of patients with a high probability of developing CVD. Trial Registration ClinicalTrials.gov identifier, UMIN000032325. |
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書誌情報 |
en : Diabetes therapy 巻 10, 号 5, p. 1565-1575, 発行日 2019-10 |
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ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 1869-6953 | |||||
PubMed番号 | ||||||
識別子タイプ | PMID | |||||
関連識別子 | 31338757 | |||||
DOI | ||||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1007/s13300-019-0665-8 | |||||
権利 | ||||||
権利情報 | © The Author(s) 2019 | |||||
権利 | ||||||
権利情報 | This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/ by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. | |||||
著者版フラグ | ||||||
値 | publisher | |||||
出版者 | ||||||
出版者 | Springer |