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The Finnish Diabetes Prevention Study (DPS)

Primary Purpose

Type 2 Diabetes

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Intensive lifestyle counselling
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Type 2 diabetes, primary prevention, diet, physical activity, intervention, impaired glucose tolerance, lifestyle, randomized controlled study

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Population Health Unit, Department of Public Health and Welfare, Finnish Institute for Health and Welfare
  • Institute of Public Health and Clinical Nutrition, University of Eastern Finland
  • Department of Sports Medicine, Oulu Deaconess Institute
  • The Diabetes Center, Finnish Diabetes Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Intensive lifestyle intervention

Standard counselling at baseline

Outcomes

Primary Outcome Measures

Diabetes incidence

Secondary Outcome Measures

CVD incidence

Full Information

First Posted
August 16, 2007
Last Updated
September 13, 2023
Sponsor
Finnish Institute for Health and Welfare
Collaborators
University of Eastern Finland, Finnish Diabetes Association, University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT00518167
Brief Title
The Finnish Diabetes Prevention Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1993 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Finnish Institute for Health and Welfare
Collaborators
University of Eastern Finland, Finnish Diabetes Association, University of Oulu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, primary prevention, diet, physical activity, intervention, impaired glucose tolerance, lifestyle, randomized controlled study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
522 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Intensive lifestyle intervention
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard counselling at baseline
Intervention Type
Behavioral
Intervention Name(s)
Intensive lifestyle counselling
Intervention Description
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
Primary Outcome Measure Information:
Title
Diabetes incidence
Time Frame
During the intervention period + after the intervention has been stopped
Secondary Outcome Measure Information:
Title
CVD incidence
Time Frame
During the total follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaakko Tuomilehto, professor emeritus
Organizational Affiliation
Finnish Institute for Health and Welfare and University of Helsinki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matti Uusitupa, professor emeritus
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Population Health Unit, Department of Public Health and Welfare, Finnish Institute for Health and Welfare
City
Helsinki
Country
Finland
Facility Name
Institute of Public Health and Clinical Nutrition, University of Eastern Finland
City
Kuopio
Country
Finland
Facility Name
Department of Sports Medicine, Oulu Deaconess Institute
City
Oulu
Country
Finland
Facility Name
The Diabetes Center, Finnish Diabetes Association
City
Tampere
Country
Finland

12. IPD Sharing Statement

Citations:
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de Mello VD, Lindstrom J, Eriksson J, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Sundvall J, Laakso M, Tuomilehto J, Uusitupa M. Insulin secretion and its determinants in the progression of impaired glucose tolerance to type 2 diabetes in impaired glucose-tolerant individuals: the Finnish Diabetes Prevention Study. Diabetes Care. 2012 Feb;35(2):211-7. doi: 10.2337/dc11-1272. Epub 2011 Dec 30.
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Siitonen N, Pulkkinen L, Lindstrom J, Kolehmainen M, Schwab U, Eriksson JG, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M. Association of ADIPOR2 gene variants with cardiovascular disease and type 2 diabetes risk in individuals with impaired glucose tolerance: the Finnish Diabetes Prevention Study. Cardiovasc Diabetol. 2011 Sep 24;10:83. doi: 10.1186/1475-2840-10-83.
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PubMed Identifier
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Siitonen N, Pulkkinen L, Lindstrom J, Kolehmainen M, Eriksson JG, Venojarvi M, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Uusitupa M. Association of ADIPOQ gene variants with body weight, type 2 diabetes and serum adiponectin concentrations: the Finnish Diabetes Prevention Study. BMC Med Genet. 2011 Jan 10;12:5. doi: 10.1186/1471-2350-12-5.
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PubMed Identifier
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Uusitupa MI, Stancakova A, Peltonen M, Eriksson JG, Lindstrom J, Aunola S, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Tuomilehto J, Laakso M. Impact of positive family history and genetic risk variants on the incidence of diabetes: the Finnish Diabetes Prevention Study. Diabetes Care. 2011 Feb;34(2):418-23. doi: 10.2337/dc10-1013. Epub 2010 Oct 27.
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Ilanne-Parikka P, Laaksonen DE, Eriksson JG, Lakka TA, Lindstr J, Peltonen M, Aunola S, Keinanen-Kiukaanniemi S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Leisure-time physical activity and the metabolic syndrome in the Finnish diabetes prevention study. Diabetes Care. 2010 Jul;33(7):1610-7. doi: 10.2337/dc09-2155. Epub 2010 Apr 22.
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19651919
Citation
Tuomilehto H, Peltonen M, Partinen M, Lavigne G, Eriksson JG, Herder C, Aunola S, Keinanen-Kiukaanniemi S, Ilanne-Parikka P, Uusitupa M, Tuomilehto J, Lindstrom J; Finnish Diabetes Prevention Study Group. Sleep duration, lifestyle intervention, and incidence of type 2 diabetes in impaired glucose tolerance: The Finnish Diabetes Prevention Study. Diabetes Care. 2009 Nov;32(11):1965-71. doi: 10.2337/dc08-1980. Epub 2009 Aug 3.
Results Reference
derived
PubMed Identifier
19130041
Citation
Herder C, Peltonen M, Koenig W, Sutfels K, Lindstrom J, Martin S, Ilanne-Parikka P, Eriksson JG, Aunola S, Keinanen-Kiukaanniemi S, Valle TT, Uusitupa M, Kolb H, Tuomilehto J; Finnish Diabetes Prevention Study Group. Anti-inflammatory effect of lifestyle changes in the Finnish Diabetes Prevention Study. Diabetologia. 2009 Mar;52(3):433-42. doi: 10.1007/s00125-008-1243-1. Epub 2009 Jan 8.
Results Reference
derived
PubMed Identifier
18252900
Citation
Lindstrom J, Peltonen M, Eriksson JG, Aunola S, Hamalainen H, Ilanne-Parikka P, Keinanen-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. doi: 10.2337/dc07-2162. Epub 2008 Feb 5.
Results Reference
derived

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