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Intensity of Exercise and Glucose Metabolism (PreDiabEx)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by University of Oulu.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborators:
Finnish Diabetes Association
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01649219
First received: July 21, 2012
Last updated: July 24, 2012
Last verified: July 2012

July 21, 2012
July 24, 2012
January 2010
June 2010   (final data collection date for primary outcome measure)
Glucose and lipid metabolism [ Time Frame: 3-month intervention ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Changes in muscle metabolism [ Time Frame: 3-months intervention ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intensity of Exercise and Glucose Metabolism
Not Provided
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prediabetes
Behavioral: Exercise
  • Experimental: Exercise intervention
    3-month supervised exercise intervention 3 times per week; 60min per time.
    Intervention: Behavioral: Exercise
  • No Intervention: No intervention
    Standard couselling at baseline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
June 2013
June 2010   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01649219
64/2009
No
Not Provided
Not Provided
University of Oulu
University of Oulu
  • Finnish Diabetes Association
  • Oulu University Hospital
Principal Investigator: Karl-Heinz Herzig, MD,PhD University of Oulu
University of Oulu
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP