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Intensity of Exercise and Glucose Metabolism (PreDiabEx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01649219
Recruitment Status : Unknown
Verified July 2012 by University of Oulu.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : July 25, 2012
Sponsor:
Collaborators:
Finnish Diabetes Association
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu

Tracking Information
First Submitted Date  ICMJE July 21, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date July 25, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Glucose and lipid metabolism [ Time Frame: 3-month intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Changes in muscle metabolism [ Time Frame: 3-months intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensity of Exercise and Glucose Metabolism
Official Title  ICMJE Not Provided
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prediabetes
Intervention  ICMJE Behavioral: Exercise
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 24, 2012)
80
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649219
Other Study ID Numbers  ICMJE 64/2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oulu
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE
  • Finnish Diabetes Association
  • Oulu University Hospital
Investigators  ICMJE
Principal Investigator: Karl-Heinz Herzig, MD,PhD University of Oulu
PRS Account University of Oulu
Verification Date July 2012

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