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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 1 diabetes—JDCP study 2

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Abstract

The JDCP study is a large-scale, prospective observational study designed to elucidate risk factors for diabetic complications as they become manifest in Japanese type 1 and 2 diabetic patients in the course of their observation and follow-up. Of the 6338 patients enrolled in the study, all patients with type 1 diabetes (n = 394) were examined for baseline clinical characteristics, which were summarized as follows: men, n = 174 (44 %); mean age (men/women), 55.3/56.8 years; duration of diabetes, 11.9/11.1 years; and those with a family history of diabetes, 27.7 %/35.6 %; BMI, 22.4/21.8 kg/m2 (P = 0.048); HbA1c, 7.9/7.7 %; those with HbA1c < 7 %, 23.1/26.9 %; SBP, 126.0/124.9 mmHg; and LDL-C, 106.1/107.7 mg/dL. Additionally, the insulin dose per patient was shown to be 33.0 U or 0.58 U/kg body weight with self-monitoring of blood glucose being used in 95.8 % of the patients.

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References

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Acknowledgments

The JDCP study is a Japan Diabetes Society (JDS)-originated research project. The study was supported by Ministry of Health, Labour and Welfare grants-in-aid during the 2009–2010 period and then by JDS grants-in-aid from 2011 onwards. The project also received research grants from the Manpei Suzuki Diabetes Foundation to provide support in registry configuration that had to do with data collection. The JDCP study investigators would like to thank all physicians and their staff at the participating institutions for their cooperation and assistance in the conduct of the study. Their heartfelt thanks are also due to all diabetic patients for their participation in the study from all parts of Japan.

Author information

Authors and Affiliations

  1. Japan Diabetes Society, Tokyo, Japan

    Rimei Nishimura, Kazuo Izumi, Yasuaki Hayashino, Hideki Origasa, Mitsuhiko Noda, Kohjiro Ueki & Naoko Tajima

  2. Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, 3-25-8 Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan

    Rimei Nishimura

  3. Japan Agency for Medical Research and Development, Tokyo, Japan

    Kazuo Izumi

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

    Mitsuhiko Noda

  7. Department of Endocrinology and Diabetes, Saitama Medical University, 38 Moro-hongo, Moroyama, Iruma-gun, Saitama, Japan

    Mitsuhiko Noda

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

    Kohjiro Ueki

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

    Kohjiro Ueki

  10. Jikei University School of Medicine, Tokyo, Japan

    Naoko Tajima

Authors
  1. Rimei Nishimura
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  2. Kazuo Izumi
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  3. Yasuaki Hayashino
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  4. Hideki Origasa
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  5. Mitsuhiko Noda
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  6. Kohjiro Ueki
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  7. Naoko Tajima
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Corresponding author

Correspondence to Rimei Nishimura.

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Conflict of interest

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

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Nishimura, R., Izumi, K., Hayashino, Y. 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 1 diabetes—JDCP study 2. Diabetol Int 7, 4–11 (2016). https://doi.org/10.1007/s13340-015-0248-5

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