Diabetes Mellitus, Type 2NCT00945165
Exercise and Glycemic Control in Type 2 Diabetes
A study testing Exercise intervention and No exercise in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Hyperglycemia is an independent risk factor for the development of diabetic complications in type 2 diabetes. Exercise improves glycemic control, however, the role of exercise characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be elucidated. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperglycemia
- What is being tested?
- Exercise intervention and No exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2009to Jun 2012
- 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 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 25 - 35 kg/m2
- Impaired Glucose Tolerant (according to ADA guidelines)
- BMI 25 - 35 kg/m2
- Insulin therapy
- diagnosed with type 2 diabetes >2 yr
- BMI 25 - 35 kg/m2
- diagnosed with type 2 diabetes >2 yr
Who cannot join
- Cardiac disease (cardiac event in the last 5 years)
- Type 2 diabetes
- Use of orale blood glucose lowering medication or exogenous insulin
- HbA1c >10%
- Insulin treated type 2 diabetes patients
- Cardiac disease (cardiac event in the last 5 years)
Show all 11Show fewer
- HbA1c >10%
- Type 2 diabetes patients on oral blood glucose lowering medication
- Cardiac disease (cardiac event in the last 5 years)
- HbA1c >10%
- use of exogenous insulin
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6200 MD
About this study
Official title: Defining the Optimal Exercise Program to Improve Glycemic Control in Various Stages of Type 2 Diabetes.
Hyperglycemia is an independent risk factor for the development of diabetic complications in type 2 diabetes. Exercise improves glycemic control, however, the role of exercise characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be elucidated.
This study aims to assess the effect of several exercise characteristics on hyperglycemia in various subgroups of type 2 diabetes patiënts.
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia
- Being tested
- Exercise intervention, No exercise
- Keywords
- Continuous Glucose Monitoring System, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
various exercise characteristics
No exerciseBehavioural
No exercise control period
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Exercise intervention |
| No exercise | Experimental | Not described Receives: Behavioral: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperglycemia
Measured: 24h
Secondary outcomes (1)
Mean Blood Glucose
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Maastricht University Medical CenterThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Jan-Willem M van Dijk, MSc, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945165
- Sponsor's protocol ID
- 09-3-028
- Status last verified
- Oct 2012
- First submitted
- 23 Jul 2009
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26.
PubMed 24583293van Dijk JW, Venema M, van Mechelen W, Stehouwer CD, Hartgens F, van Loon LJ. Effect of moderate-intensity exercise versus activities of daily living on 24-hour blood glucose homeostasis in male patients with type 2 diabetes. Diabetes Care. 2013 Nov;36(11):3448-53. doi: 10.2337/dc12-2620. Epub 2013 Sep 16.
PubMed 24041682van Dijk JW, Tummers K, Stehouwer CD, Hartgens F, van Loon LJ. Exercise therapy in type 2 diabetes: is daily exercise required to optimize glycemic control? Diabetes Care. 2012 May;35(5):948-54. doi: 10.2337/dc11-2112. Epub 2012 Mar 7.
PubMed 22399700van Dijk JW, Manders RJ, Tummers K, Bonomi AG, Stehouwer CD, Hartgens F, van Loon LJ. Both resistance- and endurance-type exercise reduce the prevalence of hyperglycaemia in individuals with impaired glucose tolerance and in insulin-treated and non-insulin-treated type 2 diabetic patients. Diabetologia. 2012 May;55(5):1273-82. doi: 10.1007/s00125-011-2380-5. Epub 2011 Nov 29.
PubMed 22124605
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Optimal Exercise Program to Improve Glycemic Control in Various Stages of Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00945165
- Acronym / sponsor ID
- 09-3-028
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia
- Keywords
- Continuous Glucose Monitoring System, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jul 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Jul 2009 (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.
Hyperglycemia is an independent risk factor for the development of diabetic complications in type 2 diabetes. Exercise improves glycemic control, however, the role of exercise characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be elucidated.
This study aims to assess the effect of several exercise characteristics on hyperglycemia in various subgroups of type 2 diabetes patiënts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise intervention |
| No exercise | Experimental | Behavioral: No exercise |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI 25 - 35 kg/m2
- Impaired Glucose Tolerant (according to ADA guidelines)
- BMI 25 - 35 kg/m2
- Insulin therapy
- diagnosed with type 2 diabetes >2 yr
Key exclusion criteria (11 listed)
- Cardiac disease (cardiac event in the last 5 years)
- Type 2 diabetes
- Use of orale blood glucose lowering medication or exogenous insulin
- HbA1c >10%
- Insulin treated type 2 diabetes patients
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 |
|---|---|---|
| Exercise interventionvarious exercise characteristics | Behavioural | Exercise |
| No exerciseNo exercise control period | Behavioural | No exercise |
Primary outcome
Hyperglycemia
Time frame: 24h
1 secondary outcome
Mean Blood Glucose
Time frame: 24h
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 25 Oct 2012.
- Derived from this study: PubMed 24583293Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26.
- Derived from this study: PubMed 24041682van Dijk JW, Venema M, van Mechelen W, Stehouwer CD, Hartgens F, van Loon LJ. Effect of moderate-intensity exercise versus activities of daily living on 24-hour blood glucose homeostasis in male patients with type 2 diabetes. Diabetes Care. 2013 Nov;36(11):3448-53. doi: 10.2337/dc12-2620. Epub 2013 Sep 16.
- Derived from this study: PubMed 22399700van Dijk JW, Tummers K, Stehouwer CD, Hartgens F, van Loon LJ. Exercise therapy in type 2 diabetes: is daily exercise required to optimize glycemic control? Diabetes Care. 2012 May;35(5):948-54. doi: 10.2337/dc11-2112. Epub 2012 Mar 7.
- Derived from this study: PubMed 22124605van Dijk JW, Manders RJ, Tummers K, Bonomi AG, Stehouwer CD, Hartgens F, van Loon LJ. Both resistance- and endurance-type exercise reduce the prevalence of hyperglycaemia in individuals with impaired glucose tolerance and in insulin-treated and non-insulin-treated type 2 diabetic patients. Diabetologia. 2012 May;55(5):1273-82. doi: 10.1007/s00125-011-2380-5. Epub 2011 Nov 29.
- Website Muscle Metabolism MaastrichtLink provided by the sponsor.
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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.
Jan-Willem M van Dijk, MSc principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention and No exercise in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 inclusion and 11 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 25 Oct 2012. 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 Netherlands. 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?
Hyperglycemia (time frame: 24h). 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 NCT00945165, which also lists 4 linked publications.
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 25 Oct 2012.