title: Cohort profile: The Japan diabetes complications study: a long-term follow-up of a randomised lifestyle intervention study of type 2 diabetes.
abstract: The Japan Diabetes Complications Study, a randomised lifestyle intervention study of type 2 diabetes conducted at 59 institutes throughout Japan that enrolled 2033 eligible patients from January 1995 to March 1996, was directed at: (i) determining the incidence and progression rates of complications of diabetes; (ii) exploring clinical risk factors for complications of diabetes; and (iii) determining the association between lifestyle factors, including diet and physical activity, and complications of diabetes, in addition to comparing, in a randomised manner, the effects on type 2 diabetes of an extensive lifestyle intervention and conventional treatment. The protocol for the study originally specified four study populations according to primary outcomes, consisting of: (1) a macroangiopathy group (N = 1771); (ii) a nephropathy group (N = 1607); (iii) a retinopathy-incident group (N = 1221); and (iv) a retinopathy-progression group (N = 410). The primary outcomes were: (i) development of retinopathy; (ii) progression of retinopathy; (iii) development of overt nephropathy; and (iv) occurrence of macroangiopathic events including proven coronary heart disease and stroke. The study was originally planned to follow patients for 8 years, and an extended follow-up is ongoing. Information about primary outcomes, laboratory tests, and other clinical variables for each patient was collected at a central data centre through an annual report from each investigator. Additionally, extensive lifestyle surveys were conducted at baseline and 5 years after the beginning of the study intervention in both the intervention and conventional treatment groups. A description of the occurrence of complications of diabetes and of all-cause mortality, provided in this paper, demonstrated a clear gender-based difference in cardiovascular disease and all-cause mortality.
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Tanaka
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Sachiko
authors.initials: S
authors.lastname: Tanaka
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Iimuro
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Yamashita
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Shigehiro
authors.initials: S
authors.lastname: Katayama
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Akanuma
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Yamada
authors.affiliation: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan, EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan, Department of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan, Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan, Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan, Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, Tsukuba, Ibaraki, Japan and Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan jdcstudy@md.tsukuba.ac.jp.
authors.forename: Hirohito
authors.initials: H
authors.lastname: Sone
mesh_terms: D000368:Aged; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000628:therapy; D003925:Diabetic Angiopathies / Q000209:etiology / Q000628:therapy; D003928:Diabetic Nephropathies / Q000209:etiology* / Q000628:therapy; D003930:Diabetic Retinopathy / Q000209:etiology* / Q000628:therapy; D003927:Diet, Diabetic; D018450:Disease Progression; D005081:Exercise Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008019:Life Style; D008297:Male; D008875:Middle Aged
keywords: Cardiovascular disease; dietary survey; nephropathy; physical activity; retinopathy