, Volume 53, Issue 3, pp 419-428

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

Long-term lifestyle intervention lowers the incidence of stroke in Japanese patients with type 2 diabetes: a nationwide multicentre randomised controlled trial (the Japan Diabetes Complications Study)

  • H. SoneAffiliated withDepartment of Internal Medicine, University of Tsukuba Institute of Clinical Medicine
  • , S. TanakaAffiliated withLaboratory of Biostatistics, Tokyo University of Science
  • , S. IimuroAffiliated withDepartment of Biostatistics, University of Tokyo School of Medicine
  • , S. TanakaAffiliated withTranslational Research Center, Kyoto University
  • , K. OidaAffiliated withFukui Chuo Clinic
  • , Y. YamasakiAffiliated withCenter for Advanced Science and Innovation, Osaka University
  • , S. OikawaAffiliated withDepartment of Medicine, Nippon Medical School
  • , S. IshibashiAffiliated withDepartment of Endocrinology and Metabolism, Jichi Medical College
  • , S. KatayamaAffiliated withThe Fourth Department of Medicine, Saitama Medical School
    • , H. YamashitaAffiliated withDepartment of Ophthalmology, Yamagata University School of Medicine
    • , H. ItoAffiliated withTokyo Metropolitan Geriatric Hospital
    • , Y. YoshimuraAffiliated withDepartment of Nutrition, Shikoku University
    • , Y. OhashiAffiliated withDepartment of Biostatistics, University of Tokyo School of Medicine
    • , Y. AkanumaAffiliated withThe Institute for Adult Diseases, Asahi Life Foundation
    • , N. YamadaAffiliated withDepartment of Internal Medicine, University of Tsukuba Institute of Clinical Medicine Email author 
    • , for the Japan Diabetes Complications Study Group



The aim of the study was to clarify whether a therapeutic intervention focused on lifestyle modification affected the incidence of vascular complications in patients with established diabetes.


A total of 2,033 eligible Japanese men and women aged 40–70 years with type 2 diabetes from 59 institutes were randomised to a conventional treatment group (CON), which continued to receive the usual care, and a lifestyle intervention group (INT), which received education on lifestyle modification regarding dietary habits, physical activities and adherence to treatment by telephone counselling and at each outpatient clinic visit, in addition to the usual care. Randomisation and open-label allocation were done by a central computer system. Primary analysis regarding measurements of control status and occurrence of macro- and microvascular complications was based on 1,304 participants followed for an 8 year period.


Although status of control of most classic cardiovascular risk factors, including body weight, glycaemia, serum lipids and BP, did not differ between groups during the study period, the incidence of stroke in the INT group (5.48/1,000 patient-years) was significantly lower than in the CON group (9.52/1,000 patient-years) by Kaplan–Meier analysis (p = 0.02 by logrank test) and by multivariate Cox analysis (HR 0.62, 95% CI 0.39–0.98, p = 0.04). The incidence of CHD, retinopathy and nephropathy did not differ significantly between groups. Lipoprotein(a) was another significant independent risk factor for stroke.


These findings suggest that lifestyle modification had limited effects on most typical control variables, but did have a significant effect on stroke incidence in patients with established type 2 diabetes.

Clinical Trial Registration: UMIN-CTR C000000222

Funding: The Ministry of Health, Labour and Welfare, Japan


Complications Lifestyle intervention Patient education Stroke