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A large-scale, observational study to investigate the current status of diabetes complications and their prevention in Japan: research outline and baseline data for type 2 diabetes—JDCP study 1

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Abstract

The Japan Diabetes Complication and its Prevention prospective (JDCP) study is a large-scale observational study conducted to investigate the current status of the management of people with diabetes, and to clarify the risk factors for the onset and progression of diabetes complications. The study includes 6338 patients aged 40 to <75 years who had received regular outpatient treatment from 2007–2009 at medical facilities nationwide specializing in diabetes. The primary endpoints for the study include occurrence and/or progression of nephropathy, retinopathy, neuropathy, macroangiopathy, and periodontal disease; the secondary endpoints include occurrence of malignancy and mortality. This report gives an outline of the study and a summary of the baseline data for participating patients with type 2 diabetes (n = 5944). The baseline characteristics were: men, 60.1 %; mean age, 61.4 years; duration of diabetes, 10.8 years; family history of diabetes, 52.8 %; BMI, 24.5 kg/m2; HbA1c, 7.4  % (achievement of <7.0, 40.6 %); blood pressure, 129.8/74.8 mmHg; and non-HDL-C, 137.6 mg/dL. Treatments included: diet therapy alone, 10.4 %, oral hypoglycemic agents, 62.1 %; and insulin therapy, 27.5 %. The cohort is to be followed up for at least 5 years, with a high follow-up rate. The focus of the study is to develop a clinical registry that is reliable and versatile and to bring the research findings and insights to bear on the society’s Treatment Guide for Diabetes.

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References

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Acknowledgments

The JDCP study is a Japan Diabetes Society (JDS)-initiated research project. The study was supported by a Ministry of Health, Labour and Welfare grant-in-aid during the 2009–2010 period and then by JDS grants-in-aid from 2011 onwards. The project also has received research grants from the Manpei Suzuki Diabetes Foundation since 2006 to provide support in registry configuration that had to do with the data collection. The JDCP study investigators believe that the JDCP study will have relevant contributions to make toward preventing the onset or progression of diabetic complications only when they have completed the study with a high follow-up rate as a prospective observational study. The JDCP study investigators would like to thank all physicians and their staff at the 464 participating institutions for their cooperation and assistance in the conduct of the study. The JDCP study investigators also wish to extend their heartfelt thanks to diabetic patients from all parts of Japan for their participation in the study.

Author information

Authors and Affiliations

  1. Jikei University School of Medicine, 3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, Japan

    Naoko Tajima

  2. Division of Diabetes, Department of Internal Medicine, Metabolism and Endocrinology, Jikei University School of Medicine, Tokyo, Japan

    Rimei Nishimura

  3. The National Center for Global Health and Medicine, Tokyo, Japan

    Kazuo Izumi & Mitsuhiko Noda

  4. Tenri Hospital, Nara, Japan

    Yasuaki Hayashino

  5. Department of Biostatistics and Clinical Epidemiology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan

    Hideki Origasa

  6. Department of Molecular Science on Diabetes, Graduate School of Medicine, University of Tokyo, Tokyo, Japan

    Kohjiro Ueki

  7. Department of Molecular Diabetic Medicine, Diabetes Research Center, Research Institute, National Center for Global Health and Medicine, Tokyo, Japan

    Kohjiro Ueki

Authors
  1. Naoko Tajima
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  2. Rimei Nishimura
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  3. Kazuo Izumi
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  4. Yasuaki Hayashino
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Consortia

For the Diabetes Registry Configuration Committee, the Japanese Diabetes Society

Corresponding author

Correspondence to Naoko Tajima.

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Conflict of interest

Naoko Tajima has served as a speaker for MSD, Takeda Pharmaceutical Company Ltd., Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., and Novo Nordisk Pharma Ltd.. Rimei Nishimura has served as a speaker for Astellas Pharma Inc., Takeda Pharmaceutical Company Ltd., Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., and Novo Nordisk Pharma Ltd.. Mitsuhiko Noda has served as a speaker for Taisho Toyama Pharmaceutical Co., Ltd.. Kohjiro Ueki has served as a speaker for MSD, Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd, received clinical research grants from AstraZeneca and Sanofi, and was endowed lectures by MSD, Nippon Boehringer Ingelheim Co., Ltd., and Novo Nordisk Pharma Ltd..

Ethical considerations

In this study, the Declaration of Helsinki and the “Ethical Guidelines in Epidemiological Research” compiled by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare of Japan (as applicable in the study period) [3] were followed to obtain informed consent from study participants, to protect their rights and welfare, and to protect them against any potential harm and risk associated with the conduct of the study. The informed consent form as part of the study protocol clearly stated that ophthalmologic and dental examinations were to be conducted as appropriate in routine care settings to ensure no additional time or financial burden on the part of the patient being examined. This study, currently registered with the University Hospital Medical Information Network Center (UMIN000016519), was approved by the JDS Ethics Review Committee for Scientific Surveys and Studies and by the ethics committee of each participating institution. An ad hoc ethics committee was convened at the request of the principal investigator if the required review process was not feasible at any participating institution. Care was also taken to ensure that all data obtained from the study was anonymized in a linkable fashion to protect the privacy of all study participants.

Additional information

The Japan Diabetes Society launched the Diabetes Registry Configuration Committee to conduct the Japan Diabetes Complication and its Prevention prospective (JDCP) study, which reported, in Japanese, the results of a large-scale observational study to investigate the current status of diabetes complications and their prevention in Japan [1]. This is an English version of that report.

Appendix

Appendix

  1. 1.

    JDCP Study Investigators

    • JDCP Study Working Groups (representatives shown with an asterisk [*])

      • Nephropathy: Kazunori Utsunomiya, Daisuke Koya, Kenichi Shikata*

      • Retinopathy: Shigehiko Kitano*, Yukihiro Sato, Hidetoshi Yamashita

      • Neuropathy: Jiro Nakamura*, Masayuki Baba

      • Microvascular disease: Hitoshi Shimano, Yoshimitsu Yamazaki*, Naruhito Yoshioka

      • Diet therapy: Satoshi Sasaki, Jo Sato, Kinsuke Tsuda*, Nobuo Yoshiike

      • Exercise therapy: Yoshiharu Oshida, Hirohito Sone*.

      • Epidemiology/statistics: Kazuo Izumi, Hideki Origasa, Rimei Nishimura*, Yasuaki Hayashino

      • Periodontal disease: Kouji Inagaki*, Fusanori Nishimura, Hidetoshi Noguchi

    • JDCP Study Regional Leaders

      • Hokkaido Chapter: Naruhito Yoshioka

      • Tohoku Chapter: Jo Sato

      • Kanto-Koshinetsu Chapter: Naoko Tajima (Principal Investigator)

      • Chubu Chapter: Jiro Nakamura

      • Kinki Chapter: Nobuya Inagaki

      • Chugoku-Shikoku Chapter: Yukio Tanizawa

      • Kyushu Chapter: Eiichi Araki

  2. 2.

    JDCP Study Coordination Committee

    • Objective: To make key decisions relating to the research project to ensure appropriate and smooth conduct of the study.

    • Members of the Committee: Eiichi Araki, Kazuo Izumi, Nobuya Inagaki, Kohjiro Ueki, Hirohito Sone, Naoko Tajima (Chair), Yukio Tanizawa Rimei Nishimura (Secretariat), Mitsuhiko Noda, Yasuaki Hayashino.

  3. 3.

    JDCP Study Steering Committee (SSC)

    • Objective: To provide guidance on key issues in the conduct of the study, with the committee set up within the JDS; to receive reports from the SCC; to make recommendations to the SCC as required; and to assess the progress of the study as well as its outcomes and report to the JDS as to whether the study is being conducted appropriately.

    • Members of the Committee

      • (First-termers, 2009–2012): Yasuhiko Iwamoto, Masato Kasuga, Kishio Nanjo (Chair), Masakazu Haneda, Nigishi Hotta.

      • (Second-termers, 2013–): Masato Kasuga (Chair), Yasuhiro Iso, Hiroshi Kiyohara, Masakazu Haneda, Toshimasa Yamauchi, Tsutomu Yamazaki.

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Tajima, N., Nishimura, R., Izumi, K. et al. A large-scale, observational study to investigate the current status of diabetes complications and their prevention in Japan: research outline and baseline data for type 2 diabetes—JDCP study 1. Diabetol Int 6, 243–251 (2015). https://doi.org/10.1007/s13340-015-0223-1

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  • DOI: https://doi.org/10.1007/s13340-015-0223-1

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