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Trial record 1 of 15 for:    Finnish Diabetes Prevention Study
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The Finnish Diabetes Prevention Study (DPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518167
Recruitment Status : Active, not recruiting
First Posted : August 20, 2007
Last Update Posted : July 29, 2022
University of Eastern Finland
Finnish Diabetes Association
University of Oulu
Information provided by (Responsible Party):
Finnish Institute for Health and Welfare

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Intensive lifestyle counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : November 1993
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Intensive lifestyle intervention
Behavioral: Intensive lifestyle counselling

Individualized 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

No Intervention: 2
Standard counselling at baseline

Primary Outcome Measures :
  1. Diabetes incidence [ Time Frame: During the intervention period + after the intervention has been stopped ]

Secondary Outcome Measures :
  1. CVD incidence [ Time Frame: During the total follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00518167

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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, Finland
Sponsors and Collaborators
Finnish Institute for Health and Welfare
University of Eastern Finland
Finnish Diabetes Association
University of Oulu
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Principal Investigator: Jaakko Tuomilehto, professor emeritus Finnish Institute for Health and Welfare and University of Helsinki
Principal Investigator: Matti Uusitupa, professor emeritus University of Eastern Finland
Publications of Results:

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Finnish Institute for Health and Welfare Identifier: NCT00518167    
Other Study ID Numbers: KTL151-6
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
Keywords provided by Finnish Institute for Health and Welfare:
Type 2 diabetes
primary prevention
physical activity
impaired glucose tolerance
randomized controlled study
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases