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The Finnish Diabetes Prevention Study (DPS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Eastern Finland
Finnish Diabetes Association
University of Oulu
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT00518167
First received: August 16, 2007
Last updated: August 31, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Behavioral: Intensive lifestyle counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • Diabetes incidence [ Time Frame: During the intervention period + after the intervention has been stopped ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CVD incidence [ Time Frame: During the total follow up ] [ Designated as safety issue: No ]

Enrollment: 522
Study Start Date: November 1993
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518167

Locations
Finland
Diabetes Prevention Unit, Department of Health Promotion and Chronic Disease Prevention, National Institute for Health and Welfare
Helsinki, Finland
Department 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
National Institute for Health and Welfare, Finland
University of Eastern Finland
Finnish Diabetes Association
University of Oulu
Investigators
Principal Investigator: Jaakko Tuomilehto, professor National Public Health Institute and University of Helsinki
Principal Investigator: Matti Uusitupa, professor University of Eastern Finland
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT00518167     History of Changes
Other Study ID Numbers: KTL151-6
Study First Received: August 16, 2007
Last Updated: August 31, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by National Institute for Health and Welfare, Finland:
Type 2 diabetes
primary prevention
diet
physical activity
 intervention
impaired glucose tolerance
lifestyle
randomized controlled study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013