The Finnish Diabetes Prevention Study (DPS)

September 13, 2023 updated by: Finnish Institute for Health and Welfare

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

522

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diabetes incidence
Time Frame: During the intervention period + after the intervention has been stopped
During the intervention period + after the intervention has been stopped

Secondary Outcome Measures

Outcome Measure
Time Frame
CVD incidence
Time Frame: During the total follow up
During the total follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Collaborators

University of Eastern Finland
University of Oulu
Finnish Diabetes Association

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1993

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

August 16, 2007

First Posted (Estimated)

August 20, 2007

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTL151-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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