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)
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AIMS/HYPOTHESIS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS/INTERPRETATION: 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
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There is no evidence that lifestyle modifications alone decrease the risk of ASCVD in patients with DM.
“Lifestyle modification such as diet therapy817), increasing physical activity818), and smoking cessation819) are important, but there is no evidence that lifestyle modifications alone decrease the risk of ASCVD in patients with DM820, 821).”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [820]
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References 52 · Cited by 151
- Authors
- for the Japan Diabetes Complications Study Group, Sone, H., Tanaka, S., Iimuro, S., Tanaka, S., Oida, K., Yamasaki, Y., Oikawa, S., Ishibashi, S., Katayama, S., Yamashita, H., Ito, H., Yoshimura, Y., Ohashi, Y., Akanuma, Y., & Yamada, N.
- Affiliations
- University of Tsukuba (JP)
- Kyoto University (JP)
- The University of Osaka (JP)
- Nippon Medical School (JP)
- Jichi Medical University (JP)
- Yamagata University (JP)
- Shikoku University (JP)
- The Institute of Medical Science, Asahi Life Foundation (JP)
- Corresponding author
- Yamada, N.
- Venue
- Diabetologia
- Published
- 2010-01-07
- Volume
- 53
- Issue
- 3
- Pages
- 419-428
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- PMC
- PMC2815795
- OpenAlex
- W2029028244
- Cited by
- 151
- References
- 52
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 5 · 2023: 13 · 2022: 5 · 2021: 12 · 2020: 8 · 2019: 7 · 2018: 8 · 2017: 14 · 2016: 8 · 2015: 12 · 2014: 13 · 2013: 16 · 2012: 6
- FWCI
- 9.44
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- Diabetologia (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Institutional Repositories DataBase (IRDB) (publishedVersion, other-oa)
- Terrestrial Environment Research Center (University of Tsukuba) (submittedVersion, other-oa)
- Funders
- Ministry of Health, Labour and Welfare
- Japan Society for the Promotion of Science (20300227)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- type 2 diabetes, lifestyle modification, stroke incidence, vascular complications, telephone counseling, dietary habits, physical activity, lipoprotein(a), cardiovascular risk factors, retinopathy, kidney disease, coronary artery disease, glycemic control
- MeSH terms
- Adult, Aged, Diabetes Mellitus, Type 2, Diet, Female, Humans, Japan, Life Style, Male, Middle Aged, Quality of Life, Incidence, Treatment Outcome, Stroke, Diabetes Complications
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