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Japanese Type 1 Diabetes Database Study (TIDE-J): rationale and study design

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Abstract

Type 1 diabetes (T1D) is classified into three subtypes: acute-onset, slowly progressive, and fulminant T1D, according to the heterogeneity of clinical course in Japan. Although several cross-sectional databases of T1D have been reported, prospective longitudinal databases to investigate clinical outcomes are lacking in our country. Therefore, we herein construct multi-center prospective longitudinal database of the three subtypes of T1D, accompanied with genetic information and biobanking, which is named Japanese Type 1 Diabetes Database Study (TIDE-J). Inclusion criteria of this study are as follows: (1) the duration of T1D was less than 5 years, (2) the patients had one or more islet-related autoantibodies and/or fasting serum C-peptide levels were less than 1.0 ng/mL, (3) the patients could clearly understand the study consent in writing. In the TIDE-J, clinical data, including glycemic control, endogenous insulin secretion, islet-related autoantibodies, diabetic complications, and treatment, are collected annually using electric data collection system, which is named REDCap. Furthermore, HLA genotypes of each participant were analyzed at entry and the blood samples were stored for assessing exploratory markers and further genetic analysis annually. The TIDE-J certainly helps in revealing distinct clinical course of each T1D subtype. Moreover, this database may help in identifying novel markers for diagnosing each subtype of T1D and predicting clinical outcomes (including pancreatic beta cell function and disease severity) in patients.

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Data availability

The datasets generated during this study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors would like to thank the following researchers for their support during clinical data collection: Nobuyuki Takahashi, Keisuke Ueno, Aiko Terakawa, Noriko Kodani, Hidekatsu Yanai, Hisayuki, Katsuyama, and Akiko Shima from National Center for Global Health and Medicine; Jungo Terasaki, Yuko Mishiba, Norio Kanatsuna, and Akiko Irie from Osaka Medical and Pharmaceutical University; Shinsuke Noso, Junko Toma, and Yayoi Kibayashi from Kindai University; Hiromi Iwahashi, Sho Yoneda, Harutoshi Ozawa, and Shingo Fujita from Osaka University; Susumu Kurihara from Saitama Medical University; Ryoichi Kawamura and Hiroshi Onuma from Ehime University; Satoshi Akazawa and Ichiro Horie from Nagasaki University; Shoichiro Tanaka, Masahiro Kaneshige, Soichi Takizawa from Yamanashi University; Ken Yajima from Tachikawa Hospital; Yasuhisa Fujii from Takanoko Hospital; Shiori Kondo from Matsuyama Red Cross Hospital; Satoshi Murao from Takamatsu Hospital; Kyoko Kohashi from Showa University; Aira Uchida from Shin-Koga Hospital. We would also like to thank Tomoko Iwamoto from the National Center for Global Health and Medicine for the management of the collected data.

Funding

This study was supported by a grant from the National Center for Global Health and Medicine (19A1008).

Author information

Authors and Affiliations

  1. Department of Diabetes, Endocrinology, and Metabolism, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku, Tokyo, 162-8655, Japan

    Daisuke Chujo & Hiroshi Kajio

  2. Center for Clinical Research, Toyama University Hospital, Toyama, Japan

    Daisuke Chujo

  3. Islet Cell Transplantation Project, National Center for Global Health and Medicine, Tokyo, Japan

    Daisuke Chujo & Masayuki Shimoda

  4. Department of Internal Medicine (I), Osaka Medical and Pharmaceutical University, Takatsuki, Japan

    Akihisa Imagawa & Toshiaki Hanafusa

  5. Department of Diabetes, Endocrinology, and Metabolism, Kyorin University, Mitaka, Japan

    Kazuki Yasuda

  6. Department of Endocrinology and Metabolism, Nagasaki University Hospital, Nagasaki, Japan

    Norio Abiru

  7. Center for University-Wide Education, School of Health and Social Service, Saitama Prefectural University, Saitama, Japan

    Takuya Awata

  8. Division of Diabetes and Endocrinology, Showa University School of Medicine, Tokyo, Japan

    Tomoyasu Fukui

  9. Department of Endocrinology, Metabolism and Diabetes, Faculty of Medicine, Kindai University, Higashi-Osaka, Japan

    Hiroshi Ikegami

  10. Diabetes Center, Shin-Koga Hospital, Kurume, Japan

    Eiji Kawasaki

  11. Department of Diabetes and Endocrinology, Tokyo Saiseikai Central Hospital, Tokyo, Japan

    Takeshi Katsuki

  12. Division of Immunology and Molecular Medicine, Okinaka Memorial Institute for Medical Research, Tokyo, Japan

    Tetsuro Kobayashi

  13. Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Suita, Japan

    Junji Kozawa

  14. Division of Diabetes, Metabolism, and Endocrine Medicine Field, Iwate Medical University, Shiwa, Japan

    Kan Nagasawa

  15. Department of Date Science, National Center for Global Health and Medicine, Tokyo, Japan

    Hiroshi Ohtsu

  16. Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Iruma, Japan

    Yoichi Oikawa & Akira Shimada

  17. Department of Diabetes and Molecular Genetics, Ehime University Graduate School of Medicine, Toon, Japan

    Haruhiko Osawa

  18. Iwate Prefectural University, Takizawa, Japan

    Kazuma Takahashi

  19. Department of Diabetes and Endocrinology, University of Yamanashi Hospital, Yamanashi, Japan

    Kyoichiro Tsuchiya

  20. Department of Diabetes and Endocrinology, Toranomon Hospital Kajigaya, Kawasaki, Japan

    Tetsuro Tsujimoto

  21. Division of Health Sciences, Department of Public Health, Kobe University Graduate School of Health Sciences, Kobe, Japan

    Hisafumi Yasuda

  22. Sakai City Medical Center, Sakai, Japan

    Toshiaki Hanafusa

Authors
  1. Daisuke Chujo
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  2. Akihisa Imagawa
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  3. Kazuki Yasuda
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  4. Norio Abiru
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  5. Takuya Awata
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  6. Tomoyasu Fukui
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  7. Hiroshi Ikegami
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  8. Eiji Kawasaki
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  9. Takeshi Katsuki
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  10. Tetsuro Kobayashi
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  11. Junji Kozawa
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  12. Kan Nagasawa
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  13. Hiroshi Ohtsu
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  14. Yoichi Oikawa
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  15. Haruhiko Osawa
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  16. Akira Shimada
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  17. Masayuki Shimoda
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  18. Kazuma Takahashi
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  19. Kyoichiro Tsuchiya
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  20. Tetsuro Tsujimoto
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  21. Hisafumi Yasuda
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  22. Toshiaki Hanafusa
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  23. Hiroshi Kajio
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Corresponding author

Correspondence to Hiroshi Kajio.

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Conflict of interest

Daisuke Chujo received honorarium for lectures from Eli Lilly and Company; research funding from Novo Nordisk Pharma Ltd., and Sanofi K.K.; Akihisa Imagawa received honorarium for lectures from Astellas Pharma Inc.; clinical commissioned/joint research grant from Astra Zeneca, Soiken Inc., Taiho Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Merck KGaA, and Parexel International Inc.; research grant from Shionogi Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company, and Ono Pharmaceutical Co., Ltd.; Norio Abiru received honorarium for lectures from Novo Nordisk Pharma Ltd., Astellas Pharma Inc., and Eli Lilly and Company; research funding from Ono Pharmaceutical Co. Ltd., Bristol Myers Squibb, Taisho Pharmaceutical Co., Ltd., and Astellas Pharma Inc.; Takuya Awata received honorarium for lectures from Astellas Pharma Inc.; Hiroshi Ikegami received honorarium for lectures from Astellas Pharma Inc., Eli Lilly and Company, MSD K.K., Novo Nordisk Pharma Ltd., Novartis Pharma K.K., Sumitomo Dainippon Pharma Co., Ltd., and Terumo Corporation; donations from Abbott Japan Co., Ltd., LifeScan Japan K.K., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Pharma Ltd., Otsuka Pharmaceutical Co., Ltd., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company. Akira Shimada received honorarium for lectures from Novo Nordisk Pharma Ltd., Eli Lilly and Company, and Sanofi K.K.; Other authors have no conflict of interest to declare.

Human rights statement and informed consent

All procedures performed were in accordance with the 1964 Helsinki Declaration and its later amendments and the “ethical guidelines for human genome/gene analysis research” published by the Ministry of Health, Labor, and Welfare of Japan. The study protocol was approved by the ethical committee of the National Center for Global Health and Medicine and other collaborating institutes (ID: NCGM-A-000138-13). Written informed consent was obtained from all participants.

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Chujo, D., Imagawa, A., Yasuda, K. et al. Japanese Type 1 Diabetes Database Study (TIDE-J): rationale and study design. Diabetol Int 13, 288–294 (2022). https://doi.org/10.1007/s13340-021-00541-2

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  • DOI: https://doi.org/10.1007/s13340-021-00541-2

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