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Intensity of Exercise and Glucose Metabolism (PreDiabEx)

The recruitment status of this study is unknown because the information has not been verified recently.
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in muscle metabolism [ Time Frame: 3-months intervention ] [ Designated as safety issue: Yes ]
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
Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01649219     History of Changes
Other Study ID Numbers: 64/2009
Study First Received: July 21, 2012
Last Updated: July 24, 2012
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on March 03, 2015