Overview

This trial is active, not recruiting.

Condition prediabetes
Treatment exercise
Phase phase 4
Sponsor University of Oulu
Collaborator Finnish Diabetes Association
Start date January 2010
End date June 2010
Trial size 80 participants
Trial identifier NCT01649219, 64/2009

Summary

Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
3-month supervised exercise intervention 3 times per week; 60min per time.
exercise
(No Intervention)
Standard couselling at baseline

Primary Outcomes

Measure
Glucose and lipid metabolism
time frame: 3-month intervention

Secondary Outcomes

Measure
Changes in muscle metabolism
time frame: 3-months intervention

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

Inclusion Criteria: - prediabetes determined by 2 hr oGTT Exclusion Criteria: - any functional limitation or chronic disease that might have limited the physical exercise and testing - vigorous physical activity/exercise as revealed by questionnaire and physician exam

Additional Information

Principal investigator Karl-Heinz Herzig, MD,PhD
Description Study type: Interventional Study design: Randomized Endpoint classification: Changes in fasting and 2 h glucose, insulin and lipid concentrations Intervention model: Parallel assignment Masking: Open label Primary purpose: Prevention and dose response assessment of exercise on glucose and lipid metabolism Condition: Prediabetes Intervention: Supervised exercise - The training sessions of the intervention group are carried out indoors 3 times a week for 3 months and supervised by an exercise instructor and physician. Each session last for 60 min and include a 5-min warm-up and stretching, a 20-min walking at speeds 2-4 km/h depending of the participant's physical condition, a 5-min stretching and balance training, a 20-min walking, and a 10-min stretching and balance training. After 1.5 months the 5-min stretching and balance training between the two 20-min walkings is excluded, and the walking time become 45 min. No intervention: control group; couseling at baseline. Participants of the control group are advised to continue their usual physical and dietary habits. Experimental: 1 -supervised exercise intervention. No intervention: 2 - standard counseling at baseline.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by University of Oulu.