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The Finnish Diabetes Prevention Study (DPS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by National Institute for Health and Welfare, Finland.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518167
First Posted: August 20, 2007
Last Update Posted: September 2, 2011
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.
Collaborators:
University of Eastern Finland
Finnish Diabetes Association
University of Oulu
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland
August 16, 2007
August 20, 2007
September 2, 2011
November 1993
December 2013   (Final data collection date for primary outcome measure)
Diabetes incidence [ Time Frame: During the intervention period + after the intervention has been stopped ]
Same as current
Complete list of historical versions of study NCT00518167 on ClinicalTrials.gov Archive Site
CVD incidence [ Time Frame: During the total follow up ]
Same as current
Not Provided
Not Provided
 
The Finnish Diabetes Prevention Study
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Type 2 Diabetes
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
  • Experimental: 1
    Intensive lifestyle intervention
    Intervention: Behavioral: Intensive lifestyle counselling
  • No Intervention: 2
    Standard counselling at baseline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
522
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00518167
KTL151-6
Yes
Not Provided
Not Provided
National Institute for Health and Welfare, Finland
National Institute for Health and Welfare, Finland
  • University of Eastern Finland
  • Finnish Diabetes Association
  • University of Oulu
Principal Investigator: Jaakko Tuomilehto, professor National Public Health Institute and University of Helsinki
Principal Investigator: Matti Uusitupa, professor University of Eastern Finland
National Institute for Health and Welfare, Finland
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP