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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:

ClinicalTrials.gov Identifier:

NCT01649219

First Posted: July 25, 2012

Last Update Posted: July 25, 2012

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.

Collaborators:

Finnish Diabetes Association

Oulu University Hospital

Information provided by (Responsible Party):

University of Oulu

Purpose

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	Intervention	Phase
Prediabetes	Behavioral: Exercise	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Prediabetes

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:

Glucose and lipid metabolism [ Time Frame: 3-month intervention ]

Secondary Outcome Measures:

Changes in muscle metabolism [ Time Frame: 3-months intervention ]


Enrollment:	80
Study Start Date:	January 2010
Estimated Study Completion Date:	June 2013
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

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 Submitted:	July 21, 2012
First Posted:	July 25, 2012
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

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