Back to resultsA Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Endurance training
strength training
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2-diabetes, exercise therapy, RCT, Norway
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with type 2-diabetes
- Male, 35-71 years
- Managing their diabetes through a lifestyle and/or the drug metformin only
- Able to participate in either of the exercise groups
Exclusion Criteria:
- Symptomatic cardiovascular disease
- Uncontrolled hypertension
- Physical or cognitive disabilities that will interfere with participating in the exercise regimes.
- Trained consistently during the last six months.
Sites / Locations
- NTNU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
endurance training
strength training
Arm Description
supervised endurance training
Supervised strength training
Outcomes
Primary Outcome Measures
HbA1C
Secondary Outcome Measures
body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides
Full Information
NCT ID
NCT00666094
First Posted
April 23, 2008
Last Updated
February 7, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00666094
Brief Title
A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes
Official Title
A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (Actual)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To test the hypothesis that there is no difference in change in HbA1C among men with type 2-diabetes after an exercise intervention with strength versus endurance training.
Detailed Description
Exercise training is well documented as part of effective treatment for type 2-diabetes patients. Endurance training has been suggested as the most suitable form of exercise. There are reasons to believe that strength training also has a positive effect. However, comparisons of endurance training and strength training regimes are limited.
Therefore we randomized 26 men with type 2-diabetes to either an endurance training group or a strength training group. Both groups exercised three sessions per week for three months. The training was supervised.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hyperglycemia
Keywords
Type 2-diabetes, exercise therapy, RCT, Norway
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endurance training
Arm Type
Active Comparator
Arm Description
supervised endurance training
Arm Title
strength training
Arm Type
Experimental
Arm Description
Supervised strength training
Intervention Type
Behavioral
Intervention Name(s)
Endurance training
Other Intervention Name(s)
Aerobic training
Intervention Description
supervised endurance training. Three sessions per week in three months.
Intervention Type
Behavioral
Intervention Name(s)
strength training
Intervention Description
Supervised strength training. Three sessions per week in three months.
Primary Outcome Measure Information:
Title
HbA1C
Time Frame
12.01.08
Secondary Outcome Measure Information:
Title
body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides
Time Frame
12.01.08
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with type 2-diabetes
Male, 35-71 years
Managing their diabetes through a lifestyle and/or the drug metformin only
Able to participate in either of the exercise groups
Exclusion Criteria:
Symptomatic cardiovascular disease
Uncontrolled hypertension
Physical or cognitive disabilities that will interfere with participating in the exercise regimes.
Trained consistently during the last six months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liv B Augestad, PhD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Study Director
Facility Information:
Facility Name
NTNU
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
Citation
Moe B, Augestad LB, Åsvold BO, Flanders WD. Effects of aerobic versus resistance training on glycaemic control in men with type 2 diabetes. European Journal of Sports Science 11(5): 365-374, 2011
Results Reference
result
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A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes
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