CClinicalTrials.gg
Status unknownNCT01649219PreDiabExUpdated Jul 25, 2012

Intensity of Exercise and Glucose Metabolism

A Phase 4 interventional study of Exercise in Prediabetes, sponsored by University of Oulu. Status unknown at 1 site in Finland. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-07-25.

Sponsored by University of Oulu · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Prediabetes

Keywords

  • Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's enrollment of 80 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • prediabetes determined by 2 hr oGTT

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Exercise intervention

    3-month supervised exercise intervention 3 times per week; 60min per time.

    Behavioral: Exercise

  • No intervention
    No intervention

    Standard couselling at baseline

Interventions

  • BehavioralExercise
06

What researchers measure

Primary outcomes

  1. Glucose and lipid metabolism

    Time frame: 3-month intervention

Secondary outcomes

  1. Changes in muscle metabolism

    Time frame: 3-months intervention

07

Study locations

1 site
  • University of Oulu
    Oulu, 90014, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01649219
Lead sponsor
University of Oulu
Collaborators
Finnish Diabetes Association, Oulu University Hospital
Responsible party
Sponsor
First posted
Jul 25, 2012
Start date
Jan 2010
Primary completion
Jun 2010
Completion
Jun 2013 (estimated)
Last update
Jul 25, 2012

Study contacts

Karl-Heinz Herzig, MD,PhD
principal investigator · University of Oulu

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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