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Intensity of Exercise and Glucose Metabolism (PreDiabEx)

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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:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Prediabetes Behavioral: Exercise Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2010
Primary Completion Date : June 2010
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Glucose and lipid metabolism [ Time Frame: 3-month intervention ]

Secondary Outcome Measures :
  1. Changes in muscle metabolism [ Time Frame: 3-months intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649219


Locations
Finland
University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Finnish Diabetes Association
Oulu University Hospital
Investigators
Principal Investigator: Karl-Heinz Herzig, MD,PhD University of Oulu
More Information

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01649219     History of Changes
Other Study ID Numbers: 64/2009
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by University of Oulu:
Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia