Diabetes Mellitus, Type 2NCT00666094
A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes
A study testing Endurance training and strength training in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 71 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperglycemia
- What is being tested?
- Endurance training and strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 71 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia
- Being tested
- Endurance training, strength training
- Keywords
- Type 2-diabetes, exercise therapy, RCT, Norway
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance trainingBehavioural
Also called Aerobic training
supervised endurance training. Three sessions per week in three months.
strength trainingBehavioural
Supervised strength training. Three sessions per week in three months.
| Study group | Role | What they receive |
|---|---|---|
| endurance training | Active comparator | supervised endurance training Receives: Behavioral: Endurance training |
| strength training | Experimental | Supervised strength training Receives: Behavioral: strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Measured: 12.01.08
Secondary outcomes (1)
body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides
Measured: 12.01.08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Liv B Augestad, PhD, Study director, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666094
- Sponsor's protocol ID
- 520073168
- Other IDs
- 520073168
- Status last verified
- Feb 2017
- First submitted
- 23 Apr 2008
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-diabetes
- ClinicalTrials.gov ID
- NCT00666094
- Acronym / sponsor ID
- 520073168
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia
- Keywords
- Type 2-diabetes, exercise therapy, RCT, Norway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Aug 2008 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endurance training | Active comparator | Behavioral: Endurance trainingsupervised endurance training |
| strength training | Experimental | Behavioral: strength trainingSupervised strength training |
Who may qualify
- Ages
- 35 to 71 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance trainingAlso: Aerobic trainingsupervised endurance training. Three sessions per week in three months. | Behavioural | endurance training |
| strength trainingSupervised strength training. Three sessions per week in three months. | Behavioural | strength training |
Primary outcome
HbA1C
Time frame: 12.01.08
1 secondary outcome
body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides
Time frame: 12.01.08
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publicationMoe 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liv B Augestad, PhD study director
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training and strength training in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: 12.01.08). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00666094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.