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Intensity of Exercise and Glucose Metabolism (PreDiabEx)

This study is ongoing, but not recruiting participants.
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
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.

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

ClinicalTrials.gov processed this record on May 19, 2013