Abstract
Aim
To examine the effect of nutritional guidance (NG) provided by a registered dietitian under the direction of a physician on the development of subsequent cardiovascular events in patients with early-stage type 2 diabetes mellitus (T2DM).
Materials and methods
This retrospective cohort study used the JMDC claims database to explore patients aged 18 years or older who first met the diagnostic criteria for T2DM at a health checkup between January 2011 and January 2019. The last day of the observation period was set for 28 February, 2021. Exposure was defined as receiving NG within 180 days of diagnosis of T2DM. The primary outcome was a composite endpoint of coronary artery disease (CAD) and cerebrovascular disease, and the secondary outcomes were each event, and time to event was compared. The propensity score weighting method was used for adjusting the distribution of confounding variables. Cox regression was conducted to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).
Results
Overall, 31,378 patients met the eligibility criteria at an annual health checkup. 9.6% received NG (n = 3013). Patients who attended ≥ 1 NG after diagnosis had significantly reduced risk of cardiovascular composite (adjusted HR 0.75, 95% CI 0.58–0.97) and cerebrovascular disease (adjusted HR 0.65, 95% CI 0.47–0.90) during approximately 3.3 years of follow-up. In contrast, no difference was observed for CAD.
Conclusions
Receiving NG in early-stage diabetes may reduce the incidence of cardiovascular events, especially cerebrovascular events.
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Acknowledgement
We thank JMDC Inc. (Tokyo, Japan) for providing claim data for analysis. We also thank the DO of DMC (http://www.dmed.co.jp), Dr. Guy Harris, and Editage (http://www.editage.jp) for their help in writing the manuscript.
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Koji Kawakami receives concurrent income from JMDC, Inc. and has received research funds from Eisai Co., Ltd., Kyowa Kirin Co., Ltd., Sumitomo Pharma Co., Ltd., Mitsubishi Corporation, and Real-World Data Co., Ltd.; consulting fees from LEBER Inc., JMDC Inc., Shin Nippon Biomedical Laboratories Ltd., and Advanced Medical Care Inc.; executive compensation from Cancer Intelligence Care Systems, Inc.; and honoraria from Mitsubishi Corporation, Pharma Business Academy, and Toppan Inc.
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This study was approved by the Ethics Committee of Kyoto University Graduate School and Faculty of Medicine (R3101). Since all data were anonymized, informed consent from the patients was not required. All procedures were conducted according to the Declaration of Helsinki. In addition, all procedures performed in studies involving human participants were following the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Nakahata, M., Tanaka-Mizuno, S., Yamaguchi, F. et al. Does nutritional guidance reduce cardiovascular events in patients with type 2 diabetes mellitus? A retrospective cohort study using a nationwide claims database. Acta Diabetol 60, 1541–1549 (2023). https://doi.org/10.1007/s00592-023-02147-3
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DOI: https://doi.org/10.1007/s00592-023-02147-3