Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatment intensive lifestyle counselling
Sponsor National Institute for Health and Welfare, Finland
Collaborator University of Eastern Finland
Start date November 1993
End date December 2013
Trial size 522 participants
Trial identifier NCT00518167, KTL151-6

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Intensive lifestyle intervention
intensive lifestyle counselling
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
(No Intervention)
Standard counselling at baseline

Primary Outcomes

Measure
Diabetes incidence
time frame: During the intervention period + after the intervention has been stopped

Secondary Outcomes

Measure
CVD incidence
time frame: During the total follow up

Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

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

Additional Information

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
Principal investigator Jaakko Tuomilehto, professor
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by National Institute for Health and Welfare, Finland.