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Horm Metab Res 2002; 34(9): 509-515
DOI: 10.1055/s-2002-34791
Original Clinical
© Georg Thieme Verlag Stuttgart · New York

Effects of Lifestyle Modifications on Patients with Type 2 Diabetes: The Japan Diabetes Complications Study (JDCS) Study Design, Baseline Analysis and Three Year-Interim Report

H.  Sone 1 , A.  Katagiri 2 , S.  Ishibashi 3 , R.  Abe 4 , Y.  Saito 5 , T.  Murase 6 , H.  Yamashita 7 , Y.  Yajima 8 , H.  Ito 9 , Y.  Ohashi 10 , Y.  Akanuma 11 , N.  Yamada 1 , JDC Study Group
  • 1Department of Internal Medicine, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, Japan
  • 2Department of Pharmacoepidemiology, School of Health Sciences and Nursing, University of Tokyo, Tokyo, Japan
  • 3Department of Metabolic Disease, School of Medicine, University of Tokyo, Tokyo, Japan
  • 4Ohta Nishinouchi Hospital, Koriyama, Fukushima, Japan
  • 5The Second Department of Internal Medicine, School of Medicine, Chiba University, Chiba, Japan
  • 6Toranomon Hospital, Tokyo, Japan
  • 7Department of Ophthalmology, School of Medicine, Yamagata University
  • 8Department of Internal Medicine, School of Medicine, Kitasato University, Sagamihara, Kanagawa
  • 9Tokyo Metropolitan Geriatric Hospital, Tama, Tokyo, Japan
  • 10Department of Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Sciences and Nursing, University of Tokyo, Tokyo, Japan
  • 11Institute for Diabetes Care and Research, Asahi Life Foundation, Tokyo, Japan
H. Sone and A. Katagiri equally contributed to this study.
Further Information

Publication History

Received: 17 October 2001

Accepted after revision: 7 May 2002

Publication Date:
17 October 2002 (online)

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Abstract

Background: Lifestyle modifications may affect the development of diabetes and prevent complications. However, there is no direct evidence to show that lifestyle intervention is beneficial for patients with established type 2 diabetes. Objective: The ultimate goal is to determine whether long-term lifestyle intervention can improve glycemic control and prevent complications in patients with type 2 diabetes. This initial report on a multi-year study describes protocols and the analysis of baseline data and three-year interim results. Design: The study was a randomized, controlled, multi-centre, prospective intervention trial. The trial included patients from 59 Japanese institutes specializing in diabetes care. Patients: The study enrolled 2 205 patients with previously diagnosed type 2 diabetes. Intervention: The lifestyle modification program included intensive lifestyle management at each outpatient clinic visit and frequent telephone counseling. The intervention group received educational materials concerning the importance of lifestyle and behavioural changes, a diary to record progress of laboratory and other data, and a pedometer. Measurements: Parameters and indices related to glycemic control, diabetic complications, dyslipidemia, hypertension, obesity, and atherosclerosis were measured several times a year. Results: Small but significant differences in HbA1c levels between the intervention (INT) and conventional (CON) therapy groups appeared as early as two years after the start of intervention and were maintained in the third year (CON group, 7.78 ± 1.27 % vs. INT group, 7.62 ± 1.20 %, the initial HbA1c level was 7.80 ± 1.42 % for the CON group and 7.68 ± 1.28 % for the INT group). Data on differences in occurrence of micro- or macrovascular complications are not yet available. Conclusions: The effect of lifestyle modification on improving the glycemic control of patients with established type 2 diabetes mellitus was small but significant three years after initiation of the intervention.

Key words

The Japan Diabetes Complications Study (JDCS) - Lifestyle Modification - Randomized Prospective Intervention Trial - Glycemic Control

References

  • 1 The Diabetes Control and Complications Trial Research Group .The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993 329: 977-986
    Google Scholar
  • 2 Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study.  Diabetes Res Clin Pract. 1995;  28 103-117
    CrossrefPubMedGoogle Scholar
  • 3 Turner R C. The U.K. Prospective Diabetes Study. A review.  Diabetes Care. 1998;  21 Suppl. 3 C35-38
    PubMedGoogle Scholar
  • 4 Ohmura T, Ueda K, Kiyohara Y, Kato I, Iwamoto H, Nakayama K, Nomiyama K, Ohmori S, Yoshitake T AS. Prevalence of type 2 (non-insulin-dependent) diabetes mellitus and impaired glucose tolerance in the Japanese general population: the Hisayama Study.  Diabetologia. 1993;  36 1198-1203
    CrossrefPubMedGoogle Scholar
  • 5 Todoroki I, Shinchi K, Kono S, Imanishi K. Lifestyle and glucose tolerance: a cross-sectional study of Japanese men.  Ann Epidemiol. 1994;  4 363-368
    PubMedGoogle Scholar
  • 6 Wannamethee S G, Shaper A G, Walker M, Ebrahim S. Lifestyle and 15-year survival free of heart attack, stroke, and diabetes in middle-aged British men.  Arch Intern Med. 1998;  158 2433-2440
    CrossrefPubMedGoogle Scholar
  • 7 Ramachandran A, Snehalatha C, Latha E, Manoharan M, Vijay V. Impacts of urbanisation on the lifestyle and on the prevalence of diabetes in native Asian Indian population.  Diabet Res Clin Pract. 1999;  44 207-213
    PubMedGoogle Scholar
  • 8 Hu F B, Manson J E, Stampfer M J, Colditz G, Liu S, Solomon C G, Willett W C. Diet, lifestyle, and the risk of type 2 diabetes mellitus in women.  N Engl J Med. 2001;  345 790-797
    CrossrefPubMedGoogle Scholar
  • 9 Byberg L, Zethelius B, McKeigue P M, Lithell H O. Changes in physical activity are associated with changes in metabolic cardiovascular risk factors.  Diabetologia. 2001;  44 2134-2139
    CrossrefPubMedGoogle Scholar
  • 10 Van Dam R M, Rimm E B, Willett W C, Stampfer M J, Hu F B. Dietary patterns and risk for type 2 diabetes mellitus in US men.  Ann Intern Med. 2002;  136 201-209
    PubMedGoogle Scholar
  • 11 Schneider S H, Khachadurian A K, Amorosa L F, Clemow L, Ruderman N B. Ten-year experience with an exercise-based outpatient life-style modification program in the treatment of diabetes mellitus.  Diabetes Care. 1992;  15 1800-1810
    CrossrefPubMedGoogle Scholar
  • 12 Franz M J. Lifestyle modifications for diabetes management.  Endocrinol Metab Clin Nor Am. 1997;  26 499-510
    PubMedGoogle Scholar
  • 13 Foreyt J P, Poston W S, 2nd . The challenge of diet, exercise and lifestyle modification in the management of the obese diabetic patient.  Int J of Obes Metab Dis. 1999;  23 S5-11
    PubMedGoogle Scholar
  • 14 Bourn D M, Mann J I, McSkimming B J, Waldron M A, Wishart J D. Impaired glucose tolerance and NIDDM: does a lifestyle intervention program have an effect?.  Diabetes Care. 1994;  17 1311-1319
    PubMedGoogle Scholar
  • 15 Pan X R, Li G W, Hu Y H, Wang J X, Yang W Y, An Z X, Hu Z X, Lin J, Xiao J Z, Cao H B, Liu P A, Jiang X G, Jiang Y Y, Wang J P, Zheng H, Zhang H, Bennett P H, Howard B V. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study.  Diabetes Care. 1997;  20 537-544
    CrossrefPubMedGoogle Scholar
  • 16 Eriksson J, Lindstrom J, Valle T, Aunola S, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Lauhkonen M, Lehto P, Lehtonen A, Louheranta A, Mannelin M, Martikkala V, Rastas M, Sundvall J, Turpeinen A, Viljanen T, Uusitupa M, Tuomilehto J. Prevention of Type II diabetes in subjects with impaired glucose tolerance: the Diabetes Prevention Study (DPS) in Finland. Study design and 1-year interim report on the feasibility of the lifestyle intervention programme.  Diabetologia. 1999;  42 793-801
    CrossrefPubMedGoogle Scholar
  • 17 Knowler W C, Barrett-Connor E, Fowler S E, Hamman R F, Lachin J M, Walker E A, Nathan D M, Group D PPR. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin.  N Engl J Med. 2002;  346 393-403
    CrossrefPubMedGoogle Scholar
  • 18 The Committee of Japan Diabetes Society for the Diagnostic Criteria of Diabetes Mellitus. Report of the Committee of Japan Diabetes Society on the Classification and Diagnostic Criteria of Diabetes Mellitus.  J Japan Diab Soc. 1999;  42 385-404
    PubMedGoogle Scholar
  • 19 Alberti K G, Zimmet P Z. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation.  Diabet Med. 1998;  15 539-553
    CrossrefPubMedGoogle Scholar
  • 20 Beaglehole R, Stewart A W, Butler M. Comparability of old and new World Health Organization criteria for definite myocardial infarction.  Int J Epidemiol. 1987;  16 373-376
    PubMedGoogle Scholar
  • 21 Tuomilehto J, Kuulasmaa K. WHO MONICA Project: assessing CHD mortality and morbidity.  Int J Epidemiol. 1989;  18 (3 Suppl. 1) S38-45
    PubMedGoogle Scholar
  • 22 The Committee of Ministry of Health, Labor and Welfare on the Diagnostic Criteria of Stroke .Report of the The Committee of Ministry of Health, Labor and Welfare on the Diagnostic Criteria of Stroke. Publication of Ministry of Health, Labor and Welfare Japan; 1984
    Google Scholar
  • 23 United Kingdom Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33).  Lancet. 1998;  352 837-853
    CrossrefPubMedGoogle Scholar
  • 24 Manson J E, Nathan D M, Krolewski A S, Stampfer M J, Willett W C, Hennekens C H. Physical activity and incidence of non-insulin-dependent diabetes mellitus in women.  Lancet. 1991;  338 774-778
    CrossrefPubMedGoogle Scholar
  • 25 Manson J E, Nathan D M, Krolewski A S, Stampfer M J, Willett W C, Hennekens C H. A prospective study of exercise and incidence of diabetes among US male physicians.  JAMA. 1992;  268 63-67
    CrossrefPubMedGoogle Scholar
  • 26 Anderssen S, Hjermann I, Urdal P, Torjesen P, Holme I. Improved carbohydrate metabolism after physical training and dietary intervention in individuals with the “atherothrombogenic syndrome”. Oslo Diet and Exercise Study (ODES). A randomized trial.  J Intern Med. 1996;  240 203-209
    CrossrefPubMedGoogle Scholar
  • 27 Eriksson K F, Lindgarde F. Prevention of type 2 (non-insulin-dependent) diabetes mellitus by diet and physical exercise. The 6-year Malmø feasibility study.  Diabetologia. 1991;  34 891-898
    CrossrefPubMedGoogle Scholar
  • 28 Bourn D M. The potential for lifestyle change to influence the progression of impaired glucose tolerance to non-insulin-dependent diabetes mellitus.  Diabet Med. 1996;  13 938-945
    CrossrefPubMedGoogle Scholar
  • 29 Uusitupa M I. Early lifestyle intervention in patients with non-insulin-dependent diabetes mellitus and impaired glucose tolerance.  Ann Med. 1996;  28 445-449
    PubMedGoogle Scholar
  • 30 Stratton I M, Adler A I, Neil H A, Matthews D R, Manley S E, Cull C A, Hadden D, Turner R C, Holman R R. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study.  Br Med J. 2000;  321 405-412
    CrossrefPubMedGoogle Scholar

Prof. N. Yamada, M.D., Ph.D.

Department of Internal Medicine · Institute of Clinical Medicine · University of Tsukuba

1-1-1 Tennodai, Tsukuba, Ibaraki · Japan (305-8575) ·

Fax: + 81 (298) 3051, 3053

Email: ymdnbhr@md.tsukuba.ac.jp