The Finnish Diabetes Prevention Study (DPS)

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The Finnish Diabetes Prevention Study (DPS)

This study is ongoing, but not recruiting participants.

Information provided by: National Public Health Institute KTL
ClinicalTrials.gov Identifier: NCT00518167

Purpose
The aim of this study is to clarify whether lifestyle intervention provided to people with high type 2 diabetes risk will lower the cumulative incidence of diabetes. Furthermore, the aim is to study the effect of lifestyle intervention on cardiovascular risk.

Condition Intervention
Type 2 Diabetes
Behavioral: Intensive lifestyle counselling

MedlinePlus related topics: Diabetes
Drug Information available for: Dextrose
U.S. FDA Resources
Study Type:Interventional
Study Design:Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:The Finnish Diabetes Prevention Study: A Follow-up Study on the Effect of a Dietary and Exercise Intervention in the Prevention of Diabetes and Its Vascular Complications

Further study details as provided by National Public Health Institute KTL:

Primary Outcome Measures:
Diabetes incidence [ Time Frame: During the intervention period + after the intervention has been stopped ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
CVD incidence [ Time Frame: During the total follow up ] [ Designated as safety issue: No ]

Enrollment:522
Study Start Date:November 1993
Estimated Study Completion Date:December 2010
Estimated Primary Completion Date:December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Intensive lifestyle intervention Behavioral: Intensive lifestyle counselling
Individualized dietary and physical activity counselling aiming at

weight reduction
dietary fibre 15 g /1000 kcal or more
energy proportion of dietary fat less than 30%
energy proportion of saturated fat less than 10%
moderate physical activity >30 minutes per day or 4 hours per week

2: No Intervention
Standard counselling at baseline

Eligibility
Ages Eligible for Study:40 Years to 65 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Yes
Criteria
Inclusion Criteria:

impaired glucose tolerance (p-glucose 2 hours after a 75 g oral glucose load between 7.8 and 11.0 mmol/l)
body mass index 25 or higher
Exclusion Criteria:

diabetes (previous gestational diabetes accepted)
other chronic disease rendering survival for 6 years
condition or medication affecting glucose tolerance
recent myocardial infarction
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518167

Locations
Finland
Diabetes Unit, Department of Epidemiology and Health Promotion, National Public Health Institute
Helsinki, Finland
Department of Public Health and Clinical Nutrition, University of Kuopio
Kuopio, Finland
Research Department, Social Insurance Institution
Turku, Finland
The Diabetes Center, Finnish Diabetes Association
Tampere, Finland
Department of Sports Medicine, Oulu Deaconess Institute
Oulu, Finland

Sponsors and Collaborators
National Public Health Institute KTL
University of Kuopio
Social Insurance Institution of Finland
Finnish Diabetes Association
University of Oulu
Investigators
Principal Investigator: Jaakko Tuomilehto, professor National Public Health Institute and University of Helsinki
Principal Investigator: Matti Uusitupa, professor University of Kuopio

Publications of Results:
Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50.
Eriksson J, Valle T, Lindstrom J, Haffner S, Louheranta A, Uusitupa M, Tuomilehto J. Leptin concentrations and their relation to body fat distribution and weight loss--a prospective study in individuals with impaired glucose tolerance. DPS-study group. Horm Metab Res. 1999 Nov;31(11):616-9.
Uusitupa M, Louheranta A, Lindstrom J, Valle T, Sundvall J, Eriksson J, Tuomilehto J. The Finnish Diabetes Prevention Study. Br J Nutr. 2000 Mar;83 Suppl 1:S137-42.
Lindi VI, Uusitupa MI, Lindstrom J, Louheranta A, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Tuomilehto J; Finnish Diabetes Prevention Study. Association of the Pro12Ala polymorphism in the PPAR-gamma2 gene with 3-year incidence of type 2 diabetes and body weight change in the Finnish Diabetes Prevention Study. Diabetes. 2002 Aug;51(8):2581-6.
Kubaszek A, Pihlajamaki J, Komarovski V, Lindi V, Lindstrom J, Eriksson J, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M, Laakso M; Finnish Diabetes Prevention Study. Promoter polymorphisms of the TNF-alpha (G-308A) and IL-6 (C-174G) genes predict the conversion from impaired glucose tolerance to type 2 diabetes: the Finnish Diabetes Prevention Study. Diabetes. 2003 Jul;52(7):1872-6.
Uusitupa M, Lindi V, Louheranta A, Salopuro T, Lindstrom J, Tuomilehto J; Finnish Diabetes Prevention Study Group. Long-term improvement in insulin sensitivity by changing lifestyles of people with impaired glucose tolerance: 4-year results from the Finnish Diabetes Prevention Study. Diabetes. 2003 Oct;52(10):2532-8.
Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003 Dec;26(12):3230-6.
Todorova B, Kubaszek A, Pihlajamaki J, Lindstrom J, Eriksson J, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M, Laakso M; Finnish Diabetes Prevention Study. The G-250A promoter polymorphism of the hepatic lipase gene predicts the conversion from impaired glucose tolerance to type 2 diabetes mellitus: the Finnish Diabetes Prevention Study. J Clin Endocrinol Metab. 2004 May;89(5):2019-23.
Laukkanen O, Pihlajamaki J, Lindstrom J, Eriksson J, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M, Laakso M; Finnish Diabetes Prevention Study Group. Common polymorphisms in the genes regulating the early insulin signalling pathway: effects on weight change and the conversion from impaired glucose tolerance to Type 2 diabetes. The Finnish Diabetes Prevention Study. Diabetologia. 2004 May;47(5):871-7. Epub 2004 May 1.
Siitonen N, Lindstrom J, Eriksson J, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Laakso M, Uusitupa M. Association between a deletion/insertion polymorphism in the alpha2B-adrenergic receptor gene and insulin secretion and Type 2 diabetes. The Finnish Diabetes Prevention Study. Diabetologia. 2004 Aug;47(8):1416-24. Epub 2004 Jul 28.
Ilanne-Parikka P, Eriksson JG, Lindstrom J, Hamalainen H, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Rastas M, Salminen V, Aunola S, Sundvall J, Valle T, Lahtela J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Prevalence of the metabolic syndrome and its components: findings from a Finnish general population sample and the Diabetes Prevention Study cohort. Diabetes Care. 2004 Sep;27(9):2135-40.
Salopuro T, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Laakso M, Uusitupa M. Common variants in beta2- and beta3-adrenergic receptor genes and uncoupling protein 1 as predictors of the risk for type 2 diabetes and body weight changes. The Finnish Diabetes Prevention Study. Clin Genet. 2004 Oct;66(4):365-7. No abstract available.
Laukkanen O, Pihlajamaki J, Lindstrom J, Eriksson J, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M, Laakso M; Finnish Diabetes Prevention Study Group. Polymorphisms of the SUR1 (ABCC8) and Kir6.2 (KCNJ11) genes predict the conversion from impaired glucose tolerance to type 2 diabetes. The Finnish Diabetes Prevention Study. J Clin Endocrinol Metab. 2004 Dec;89(12):6286-90.
Laaksonen DE, Lindstrom J, Lakka TA, Eriksson JG, Niskanen L, Wikstrom K, Aunola S, Keinanen-Kiukaanniemi S, Laakso M, Valle TT, Ilanne-Parikka P, Louheranta A, Hamalainen H, Rastas M, Salminen V, Cepaitis Z, Hakumaki M, Kaikkonen H, Harkonen P, Sundvall J, Tuomilehto J, Uusitupa M; Finnish diabetes prevention study. Physical activity in the prevention of type 2 diabetes: the Finnish diabetes prevention study. Diabetes. 2005 Jan;54(1):158-65.
Lindstrom J, Peltonen M, Tuomilehto J. Lifestyle strategies for weight control: experience from the Finnish Diabetes Prevention Study. Proc Nutr Soc. 2005 Feb;64(1):81-8. Review.
Laukkanen O, Lindstrom J, Eriksson J, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M, Laakso M; Finnish Diabetes Prevention Study. Polymorphisms in the SLC2A2 (GLUT2) gene are associated with the conversion from impaired glucose tolerance to type 2 diabetes: the Finnish Diabetes Prevention Study. Diabetes. 2005 Jul;54(7):2256-60.
Salopuro T, Pulkkinen L, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Laakso M, Uusitupa M; Finnish Diabetes Prevention Study Group. Genetic variation in leptin receptor gene is associated with type 2 diabetes and body weight: The Finnish Diabetes Prevention Study. Int J Obes (Lond). 2005 Oct;29(10):1245-51.
Hamalainen H, Ronnemaa T, Virtanen A, Lindstrom J, Eriksson JG, Valle TT, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Rastas M, Aunola S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Improved fibrinolysis by an intensive lifestyle intervention in subjects with impaired glucose tolerance. The Finnish Diabetes Prevention Study. Diabetologia. 2005 Nov;48(11):2248-53. Epub 2005 Oct 5.
Niskanen L, Laaksonen DE, Lindstrom J, Eriksson JG, Keinanen-Kiukaanniemi S, Ilanne-Parikka P, Aunola S, Hamalainen H, Tuomilehto J, Uusitupa M. Serum uric acid as a harbinger of metabolic outcome in subjects with impaired glucose tolerance: the Finnish Diabetes Prevention Study. Diabetes Care. 2006 Mar;29(3):709-11. No abstract available.
Lindstrom J, Peltonen M, Eriksson JG, Louheranta A, Fogelholm M, Uusitupa M, Tuomilehto J. High-fibre, low-fat diet predicts long-term weight loss and decreased type 2 diabetes risk: the Finnish Diabetes Prevention Study. Diabetologia. 2006 May;49(5):912-20. Epub 2006 Mar 16.
Siitonen N, Pulkkinen L, Mager U, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Laakso M, Uusitupa M. Association of sequence variations in the gene encoding adiponectin receptor 1 (ADIPOR1) with body size and insulin levels. The Finnish Diabetes Prevention Study. Diabetologia. 2006 Aug;49(8):1795-805. Epub 2006 May 25.
Mager U, Lindi V, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Laakso M, Pulkkinen L, Uusitupa M; Finnish Diabetes Prevention Study Group. Association of the Leu72Met polymorphism of the ghrelin gene with the risk of Type 2 diabetes in subjects with impaired glucose tolerance in the Finnish Diabetes Prevention Study. Diabet Med. 2006 Jun;23(6):685-9.
Herder C, Peltonen M, Koenig W, Kraft I, Muller-Scholze S, Martin S, Lakka T, Ilanne-Parikka P, Eriksson JG, Hamalainen H, Keinanen-Kiukaanniemi S, Valle TT, Uusitupa M, Lindstrom J, Kolb H, Tuomilehto J. Systemic immune mediators and lifestyle changes in the prevention of type 2 diabetes: results from the Finnish Diabetes Prevention Study. Diabetes. 2006 Aug;55(8):2340-6.
Mager U, Kolehmainen M, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto JO, Pulkkinen L, Uusitupa MI; Finnish Diabetes Prevention Study Group. Association between ghrelin gene variations and blood pressure in subjects with impaired glucose tolerance. Am J Hypertens. 2006 Sep;19(9):920-6.
Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006 Nov 11;368(9548):1673-9.
Laaksonen DE, Siitonen N, Lindstrom J, Eriksson JG, Reunanen P, Tuomilehto J, Uusitupa M; Finnish Diabetes Prevention Study Group. Physical activity, diet, and incident diabetes in relation to an ADRA2B polymorphism. Med Sci Sports Exerc. 2007 Feb;39(2):227-32.
Ottelin AM, Lindstrom J, Peltonen M, Martikainen J, Uusitupa M, Gylling H, Poutanen K, Louheranta A, Mannelin M, Paturi M, Salminen V, Tuomilehto J; Finnish Diabetes Prevention Study Group. Costs of a self-selected, health-promoting diet among the participants of the Finnish Diabetes Prevention Study. Diabetes Care. 2007 May;30(5):1275-7. Epub 2007 Feb 26. No abstract available.
Wang J, Kuusisto J, Vanttinen M, Kuulasmaa T, Lindstrom J, Tuomilehto J, Uusitupa M, Laakso M. Variants of transcription factor 7-like 2 (TCF7L2) gene predict conversion to type 2 diabetes in the Finnish Diabetes Prevention Study and are associated with impaired glucose regulation and impaired insulin secretion. Diabetologia. 2007 Jun;50(6):1192-200. Epub 2007 Apr 17.
Tolppanen AM, Pulkkinen L, Kolehmainen M, Schwab U, Lindstrom J, Tuomilehto J, Uusitupa M; Finnish Diabetes Prevention Study Group. Tenomodulin is associated with obesity and diabetes risk: the Finnish diabetes prevention study. Obesity (Silver Spring). 2007 May;15(5):1082-8.
Kilpelainen TO, Lakka TA, Laaksonen DE, Laukkanen O, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Aunola S, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M, Laakso M. Physical activity modifies the effect of SNPs in the SLC2A2 (GLUT2) and ABCC8 (SUR1) genes on the risk of developing type 2 diabetes. Physiol Genomics. 2007 Jul 17; [Epub ahead of print]

Other Publications:
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 Jul;42(7):793-801.
Lindgren P, Lindstrom J, Tuomilehto J, Uusitupa M, Peltonen M, Jonsson B, de Faire U, Hellenius ML; DPS Study Group. Lifestyle intervention to prevent diabetes in men and women with impaired glucose tolerance is cost-effective. Int J Technol Assess Health Care. 2007 Spring;23(2):177-83.

Publications indexed to this study:
Lindström J, Peltonen M, Eriksson JG, Aunola S, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study (DPS) Group. Determinants for the effectiveness of lifestyle intervention in the Finnish Diabetes Prevention Study. Diabetes Care. 2008 May;31(5):857-62. Epub 2008 Feb 5.

Responsible Party:National Public Health Institute ( Jaakko Tuomilehto, professor )
Study ID Numbers:KTL151-6
First Received:August 16, 2007
Last Updated:October 1, 2008
ClinicalTrials.gov Identifier:NCT00518167 [history]
Health Authority:Finland: Ethics Committee

Keywords provided by National Public Health Institute KTL:
Type 2 diabetes
primary prevention
diet
physical activity
intervention
impaired glucose tolerance
lifestyle
randomized controlled study

Study placed in the following topic categories:
Metabolic Diseases
Glucose Intolerance
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders