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Prevention of Diabetes Mellitus in Subjects with Impaired Glucose Tolerance in the Finnish Diabetes Prevention Study: Results From a Randomized Clinical Trial

Jaana Lindström^*, Johan G. Eriksson^*, Timo T. Valle^*, Sirkka Aunola, Zygimantas Cepaitis^*, Martti Hakumäki, Helena Hämäläinen, Pirjo Ilanne-Parikka, Sirkka Keinänen-Kiukaanniemi^¶, Mauri Laakso^**, Anne Louheranta, Marjo Mannelin^**, Vesa Martikkala^*, Vladislav Moltchanov^**, Merja Rastas, Virpi Salminen^,, Jouko Sundvall, Matti Uusitupa and Jaakko Tuomilehto^*,

*National Public Health Institute, Department of Epidemiology and Health Promotion, Diabetes and Genetic Epidemiology Unit, Helsinki; Social Insurance Institution, Research Department, Turku; University of Kuopio, Department of Clinical Nutrition, Kuopio; Finnish Diabetes Association, The Diabetes Centre, Tampere; ^¶University of Oulu, Department of Public Health Science and General Practice, Oulu; **Oulu Deaconess Institute, Department of Sports Medicine, Oulu; Institute of Nursing and Health Care, Tampere; National Public Health Institute, Department of Health and Functional Capacity, Helsinki; and University of Helsinki, Department of Public Health, Helsinki, Finland.

Correspondence to Jaakko Tuomilehto, National Public Health Institute, Mannerheimintie 166, FIN-00300 Helsinki, Finland. Phone: 358-9-4744-8635; Fax: 358-9-4744-8338;

ABSTRACT. Type 2 diabetes mellitus is increasing worldwide largely as a result from increasing obesity and sedentary lifestyle. The Finnish Diabetes Prevention Study (DPS) is the first individually randomized controlled clinical trial to test the feasibility and efficacy of lifestyle modification in high-risk subjects. We randomly assigned 522 (172 men, 350 women) middle-aged (mean age 55 yr), overweight (mean body mass index 31 kg/m²) subjects with impaired glucose tolerance either to the lifestyle intervention or control group. Each subject in the intervention group received individualized counseling aimed at reducing weight and intake of total and saturated fat, and increasing intake of fiber and physical activity. An oral glucose tolerance test was performed annually to detect incident cases of diabetes and to measure changes in metabolic parameters. The mean (± SD) weight reduction from baseline to year 1 and to year 2, respectively, was 4.2 ± 5.1 kg and 3.5 ± 5.5 in the intervention group and 0.8 ± 3.7 kg and 0.8 ± 4.4 in the control group (P < 0.001 between the groups). At the time of first analysis of the outcome data the mean duration of follow-up was 3.2 yr. The risk of diabetes was reduced by 58% (P < 0.001) in the intervention group compared with the control group. The reduction in the incidence of diabetes was directly associated with number and magnitude of lifestyle changes made. In conclusion, the DPS is the first controlled trial demonstrating that type 2 diabetes can be prevented by changes in lifestyle in high-risk subjects. E-mail: jaakko.tuomilehto@ktl.fi

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