The Finnish Diabetes Prevention Study

Type 2 Diabetes Clinical Trial

— DPS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00518167
• Other study ID #: KTL151-6
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1993
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Finnish Institute for Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 522
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

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

Locations

Country	Name	City	State
Finland	Population Health Unit, Department of Public Health and Welfare, Finnish Institute for Health and Welfare	Helsinki
Finland	Institute of Public Health and Clinical Nutrition, University of Eastern Finland	Kuopio
Finland	Department of Sports Medicine, Oulu Deaconess Institute	Oulu
Finland	The Diabetes Center, Finnish Diabetes Association	Tampere

Sponsors (4)

Lead Sponsor	Collaborator
Finnish Institute for Health and Welfare	Finnish Diabetes Association, University of Eastern Finland, University of Oulu

Country where clinical trial is conducted

Finland, 

References & Publications (35)

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. doi: 10.1007/s001250051229. — View Citation

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. Ho — View Citation

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 int — View Citation

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 — View Citation

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. Preva — View Citation

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; Finnish Diabetes Prevention Study Group. Physical activity modi — View Citation

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 — View Citation

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 — View Citation

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):2 — View Citation

Laitinen T, Lindstrom J, Eriksson J, Ilanne-Parikka P, Aunola S, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M. Cardiovascular autonomic dysfunction is associated with central obesity in persons with impaired glucose tolerance. Diabet Med. 2011 Jun;28(6):699-704. doi: 10.1111/j.1464-5491.2011.03278.x. — View Citation

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 fro — View Citation

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 ins — View Citation

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) gene — View Citation

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. doi: 10.1017/S0266462307070286. — View Citation

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 w — View Citation

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 G — View Citation

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 activit — View Citation

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- — View Citation

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. doi: 10.1079/pns2004412. — View Citation

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 pr — View Citation

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 ghreli — View Citation

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 D — View Citation

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 partici — View Citation

Pajunen P, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinanen-Kiukaanniemi S, Uusitupa M, Tuomilehto J, Lindstrom J; Finnish Diabetes Prevention Study. HbA(1c) in diagnosing and predicting Type 2 diabetes in impaired glucose tolerance: the Finn — View Citation

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 f — View Citation

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 — View Citation

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 — View Citation

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) wit — View Citation

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 lipas — View Citation

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). 2 — View Citation

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 — View Citation

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 Finni — View Citation

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. doi: 10.1017/s0007114500001070. — View Citation

Uusitupa M, Peltonen M, Lindstrom J, Aunola S, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Valle TT, Eriksson JG, Tuomilehto J; Finnish Diabetes Prevention Study Group. Ten-year mortality and cardiovascular morbidity in the Finnish Diabetes Prevention Stud — View Citation

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 i — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes incidence		During the intervention period + after the intervention has been stopped
Secondary	CVD incidence		During the total follow up