Type 2 DiabetesDPSNCT00518167
The Finnish Diabetes Prevention Study
A study testing Intensive lifestyle counselling in people with Type 2 Diabetes, run by Finnish Institute for Health and Welfare at 4 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intensive lifestyle counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 4 sitesFinland
- Study dates
- Nov 1993to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- diabetes (previous gestational diabetes accepted)
- other chronic disease rendering survival for 6 years
- condition or medication affecting glucose tolerance
- recent myocardial infarction
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Population Health Unit, Department of Public Health and Welfare, Finnish Institute for Health and Welfare
Helsinki
Institute of Public Health and Clinical Nutrition, University of Eastern Finland
Kuopio
Department of Sports Medicine, Oulu Deaconess Institute
Oulu
The Diabetes Center, Finnish Diabetes Association
Tampere
About this 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Intensive lifestyle counselling
- Keywords
- Type 2 diabetes, primary prevention, diet, physical activity, intervention, impaired glucose tolerance, lifestyle, randomized controlled study
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lifestyle counsellingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intensive lifestyle intervention Receives: Behavioral: Intensive lifestyle counselling |
| 2 | No intervention | Standard counselling at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes incidence
Measured: During the intervention period + after the intervention has been stopped
Secondary outcomes (1)
CVD incidence
Measured: During the total follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startNov 1993
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- University of Eastern Finland, Finnish Diabetes Association, University of Oulu
- Responsible party
- Sponsor
- Investigators
- Jaakko Tuomilehto, professor emeritus, Principal investigator, Finnish Institute for Health and Welfare and University of HelsinkiMatti Uusitupa, professor emeritus, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518167
- Sponsor's protocol ID
- KTL151-6
- Acronym
- DPS
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2007
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1007/s001250051229.
PubMed 10440120Lindgren 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.
PubMed 17493303Laitinen 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.
PubMed 21388444Tuomilehto 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. doi: 10.1056/NEJM200105033441801.
PubMed 11333990Eriksson 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. doi: 10.1055/s-2007-978807.
PubMed 10598830Uusitupa 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.
PubMed 10889804Lindi 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. doi: 10.2337/diabetes.51.8.2581.
PubMed 12145174Kubaszek 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. doi: 10.2337/diabetes.52.7.1872.
PubMed 12829659Uusitupa 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. doi: 10.2337/diabetes.52.10.2532.
PubMed 14514637Lindstrom 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. doi: 10.2337/diacare.26.12.3230.
PubMed 14633807Todorova 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. doi: 10.1210/jc.2003-031325.
PubMed 15126514Laukkanen 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. doi: 10.1007/s00125-004-1395-6. Epub 2004 May 1.
PubMed 15127203Siitonen 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. doi: 10.1007/s00125-004-1462-z. Epub 2004 Jul 28.
PubMed 15309292Ilanne-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. doi: 10.2337/diacare.27.9.2135.
PubMed 15333474Salopuro 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. doi: 10.1111/j.1399-0004.2004.00313.x. No abstract available.
PubMed 15355441
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00518167
- Acronym / sponsor ID
- DPS / KTL151-6
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, primary prevention, diet, physical activity, intervention, impaired glucose tolerance, lifestyle, randomized controlled study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- University of Eastern Finland, Finnish Diabetes Association, University of Oulu
- Study start
- Nov 1993
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Intensive lifestyle counsellingIntensive lifestyle intervention |
| 2 | No intervention | –Standard counselling at baseline |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- diabetes (previous gestational diabetes accepted)
- other chronic disease rendering survival for 6 years
- condition or medication affecting glucose tolerance
- recent myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive lifestyle counsellingIndividualized dietary and physical activity counselling aiming at 1. weight reduction 2. dietary fibre 15 g /1000 kcal or more 3. energy proportion of dietary fat less than 30% 4. energy proportion of saturated fat less than 10% 5. moderate physical activity >30 minutes per day or 4 hours per week | Behavioural | 1 |
Primary outcome
Diabetes incidence
Time frame: During the intervention period + after the intervention has been stopped
1 secondary outcome
CVD incidence
Time frame: During the total follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 10440120Eriksson 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.
- Background: PubMed 17493303Lindgren 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.
- Background: PubMed 21388444Laitinen 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.
- Results publication: PubMed 11333990Tuomilehto 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. doi: 10.1056/NEJM200105033441801.
- Results publication: PubMed 10598830Eriksson 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. doi: 10.1055/s-2007-978807.
- Results publication: PubMed 10889804Uusitupa 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.
- Results publication: PubMed 12145174Lindi 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. doi: 10.2337/diabetes.51.8.2581.
- Results publication: PubMed 12829659Kubaszek 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. doi: 10.2337/diabetes.52.7.1872.
- Results publication: PubMed 14514637Uusitupa 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. doi: 10.2337/diabetes.52.10.2532.
- Results publication: PubMed 14633807Lindstrom 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. doi: 10.2337/diacare.26.12.3230.
- Results publication: PubMed 15126514Todorova 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. doi: 10.1210/jc.2003-031325.
- Results publication: PubMed 15127203Laukkanen 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. doi: 10.1007/s00125-004-1395-6. Epub 2004 May 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaakko Tuomilehto, professor emeritus principal investigator
Finnish Institute for Health and Welfare and University of Helsinki
Matti Uusitupa, professor emeritus principal investigator
University of Eastern Finland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive lifestyle counselling in people with Type 2 Diabetes, run by Finnish Institute for Health and Welfare at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes incidence (time frame: During the intervention period + after the intervention has been stopped). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518167, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.