Intensity of Exercise and Glucose Metabolism (PreDiabEx)
Primary Purpose
Prediabetes
Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetes focused on measuring Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.
Eligibility 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
Sites / Locations
- University of Oulu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise intervention
No intervention
Arm Description
3-month supervised exercise intervention 3 times per week; 60min per time.
Standard couselling at baseline
Outcomes
Primary Outcome Measures
Glucose and lipid metabolism
Secondary Outcome Measures
Changes in muscle metabolism
Full Information
NCT ID
NCT01649219
First Posted
July 21, 2012
Last Updated
July 24, 2012
Sponsor
University of Oulu
Collaborators
Finnish Diabetes Association, Oulu University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01649219
Brief Title
Intensity of Exercise and Glucose Metabolism
Acronym
PreDiabEx
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
Collaborators
Finnish Diabetes Association, Oulu University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
3-month supervised exercise intervention 3 times per week; 60min per time.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Standard couselling at baseline
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Glucose and lipid metabolism
Time Frame
3-month intervention
Secondary Outcome Measure Information:
Title
Changes in muscle metabolism
Time Frame
3-months intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Herzig, MD,PhD
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oulu
City
Oulu
ZIP/Postal Code
90014
Country
Finland
12. IPD Sharing Statement
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Intensity of Exercise and Glucose Metabolism
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